DIR, DINING SERVICES SR II - Merck - North Wales

Posted 16 days ago
Job Viewed
Job Description
**Salary:**
**Other Forms of Compensation:**
**What makes FLIK click**
_What makes FLIK click? Our people. The decisions, actions and attitudes of our associates earn the trust and loyalty of our clients every day. We know how to pick them and we know how to grow them. It starts with hiring people who share our passion for food and hospitality. Once we find the right talent, we encourage, value and recognize their contributions._
_We keep our people renewed, excited and engaged by providing hands-on training and educating them about the latest trends. We give them a stake in successfully raising the bar. Our people love what they do and they love sharing their passion. Join our team and see the FLIK difference. Where a job isn't merely a job but the start of a career where you can flourish._
**Job Summary**
Working as a **Senior Director of Dining Services (Sr DDS)** , you will manage a large Corporate Services Account. You will be our point of contact for the client abd be fully responsible for foodservice, lead the teams within your assigned account(s), and manage the overall operation. You will provide planning and direction within the assigned accounts to achieve operational and financial goals in a dynamic environment, comply with all applicable regulations, maintain strong client relationships, and fulfill our mission to provide the best quality food service to our client.
**Key Responsibilities:**
+ Leads, manages, and inspires a diverse team(s) at a large account or multiple accounts, with the goal of providing top-notch service to the client and community
+ Drives and develops self and team at the account(s) towards building strong relationships with client(s) and achievement of key performance indicators (profitability, safety, engagement, etc.)
+ May serve on district leadership team, and participates in ongoing conversations with peers to share best practices, mitigate risks, champion diversity, and build community
+ Ensures decisions are weighed for risk/reward and short/long term implications, while gathering input from the team and partners
+ Fosters a culture of transparency, understanding, education, safety, and accountability
+ Serves as the representative/brand ambassador of the Flik team within the district(s) and the community
+ Ensures client(s) needs are met or exceeded, we retain the account(s), find cross-sell opportunities, and assist in rebid process as directed
+ Supports functional areas including but not limited to safety, marketing, nutrition and culinary
+ Champions development within the account(s) and has a full understanding of all roles within the operation; conducts performance evaluations, along with succession planning for the account(s)
+ Owns the financial results for the account(s), and works to ensure accuracy for reporting, forecasting, and budgeting processes
+ Ensures consistent and fair administration of all policies and procedures
**Preferred Qualifications:**
+ Bachelor's degree and minimum of three (3) years of management experience, preferably in foodservice, hospitality management, plant operations management, environmental services, laundry, or other Support Services area
+ Is well-versed in foodservice management with proven track record of success
+ Has proven track record of leading a business and a team, strong customer service, and good business and financial acumen
+ Demonstrates strong initiative, critical thinking, ownership, communications (listening, written, and verbal), multi-tasking, prioritization, and organization skills
+ Champions the inclusion mindset, and is proactive, positive, professional, and resilient
+ Excellent computer skills and proficiency with Microsoft Office suite and POS software
**Apply to Flik today!**
_Flik is a member of Compass Group USA_
Click here to Learn More about the Compass Story ( Group is an equal opportunity employer. At Compass, we are committed to treating all Applicants and Associates fairly based on their abilities, achievements, and experience without regard to race, national origin, sex, age, disability, veteran status, sexual orientation, gender identity, or any other classification protected by law.**
**Qualified candidates must be able to perform the essential functions of this position satisfactorily with or without a reasonable accommodation. Disclaimer: this job post is not necessarily an exhaustive list of all essential responsibilities, skills, tasks, or requirements associated with this position. While this is intended to be an accurate reflection of the position posted, the Company reserves the right to modify or change the essential functions of the job based on business necessity. We will consider for employment all qualified applicants, including those with a criminal history (including relevant driving history), in a manner consistent with all applicable federal, state, and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance, the San Francisco Fair Chance Ordinance, and the New York Fair Chance Act.**
Applications are accepted on an ongoing basis.
Flik maintains a drug-free workplace.
**Associates at Flik Hospitality are offered many fantastic benefits.**
+ Medical
+ Dental
+ Vision
+ Life Insurance/ AD
+ Disability Insurance
+ Retirement Plan
+ Paid Time Off
+ Holiday Time Off (varies by site/state)
+ Associate Shopping Program
+ Health and Wellness Programs
+ Discount Marketplace
+ Identity Theft Protection
+ Pet Insurance
+ Commuter Benefits
+ Employee Assistance Program
+ Flexible Spending Accounts (FSAs)
+ Paid Parental Leave
+ Personal Leave
Associates may also be eligible for paid and/or unpaid time off benefits in accordance with applicable federal, state, and local laws. For positions in Washington State, Maryland, or to be performed Remotely, click here ( for paid time off benefits information.
**Req ID:**
Flik Hospitality Group
Shane Tirpak
((req_classification))
Quality Assurance Supervisor
Posted today
Job Viewed
Job Description
Job Overview
The Supervisor, Quality Assurance (QA) will lead and develop assigned quality personnel and provide guidance for cross-functional teams to support the quality and food safety requirements of the products produced and shipped from their location. This role also supports and enforces the certification, regulatory, customer, and brand requirements as outlined by the business and implements continuous improvement projects to meet these requirements while ensuring the safety of our people, workplace and environment and meeting all company, legal and other requirements.
Duties & Responsibilities
- Supervise, lead, and motivate a team on the manufacturing floor and QA Lab to deliver results by communicating company goals; including quality and customer satisfaction, safety practices, and deadlines.
- Direction of all QA associates.
- Engage and develop teammates through effective performance management, coaching, and training.
- Implement continuous improvement methods while maintaining customer focus, and embody company purpose and values to inspire servant leadership
- Manage and support Liberty’s vision that ensures company quality assurance specifications, and regulatory requirements are met; understand and support the documentation, training, and organizational requirements for maintaining a globally recognized quality and food safety certification; serve as a program owner, and perform internal audits to ensure compliance.
- Manage the processing of laboratory data, monitor the data for accuracy through exception reporting, analyze the data, recognize unfavorable trends, and make process improvement recommendations.
- Support and assist in audits from internal and external regulatory, certification, customer, and or brand owner sources.
- Any special projects relating to Quality Assurance.
- Focus on removing costs, continuous improvement, removing inefficiencies, and complexity for the supply chain.
- Ensures that all work assessments and activities are in accordance with policies of LCCB and presiding labor agreements.
Knowledge, Skills, & Abilities
- Manufacturing experience and Food Industry knowledge
- Familiarity with lab equipment and testing within a manufacturing environment
- Math and analytical skills and problem-solving ability
- Computer skills including MS Office, statistical software, SAP preferred
- Knowledge of sanitation and beverage processes
- Must be able give direction and make critical decisions
- Knowledge of microbial and aseptic techniques
- Ability to multitask in team development, time management, and effective communication skills
- Ability to work in a fast-paced food manufacturing environment with seasonal temperatures and flexible shifts based on business needs
- Ability to stand for extended periods of time; walking manufacturing floor; climbing stairs, and lift, up to 60lbs
Minimum Qualifications
- 1 -3 years Manufacturing experience and Food Industry knowledge
- Familiarity with lab equipment and testing within a manufacturing environment
- Math and analytical skills and problem-solving ability
- Computer skills including MS Office, statistical software, SAP preferred
- Knowledge of sanitation and beverage processes
- Must be able give direction and make critical decisions
- Knowledge of microbial and aseptic techniques
- Ability to multitask in team development, time management, and effective communication skills
- Ability to work in a fast-paced food manufacturing environment with seasonal temperatures and flexible shifts based on business needs
- Ability to stand for extended periods of time; walking manufacturing floor; climbing stairs, and lift, up to 60lbs
Preferred Qualifications
- Degree or experience in Biology, Chemistry, Food Science, Health Sciences.
- Previous supervisory experience in a Manufacturing environment is an asset.
- Knowledge of water treatment systems.
- Labor relations experience is an asset.
Work Environment
- Noisy, wet, and extreme temperature environment
Quality Assurance Inspector
Posted today
Job Viewed
Job Description
Quality Operations Inspector -I
Position Summary
The Quality Assurance Inspector is responsible for providing on-the-floor quality oversight and support to ensure the compliance of manufacturing, packaging, labeling, and distribution operations with Piramal Standard Operating Procedures (SOPs) and applicable regulatory requirements. This includes adherence to Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), Data Integrity principles, and FDA regulations. The inspector plays a critical role in maintaining product quality, safety, efficacy, and regulatory compliance across operations.
Key Responsibilities
- Issue batch records in alignment with the production schedule to support timely manufacturing activities and Perform potency calculations as applicable.
- Conduct line clearance and batch readiness assessments, including verification of concurrent documentation, equipment status, and preventive maintenance records.
- Review and evaluate Environmental Monitoring (EM) data for compliance with internal standards and regulatory requirements.
- Perform BMS alarms review, acknowledgement and evaluate quality impact. Escalate critical alarms to Management.
- Perform quality oversight for water system releases used in operations.
- Perform raw material Sampling and AQL inspection of finished products.
- Review equipment logbooks and executed batch records to ensure adherence to GDP, GMP, and Data Integrity standards.
- Scan reviewed batch records and upload to share point.
- Prepare batch records and perform first release of batches.
- Perform Raw material reconciliation and investigation.
- Review and approve Calibration activities in ProCal.
- Perform QA review and approval of non-routine workorders in SAP.
- Draft, revise, and review Quality Assurance SOPs and deviation reports to ensure clarity, accuracy, and regulatory alignment.
- Conduct weekly quality surveillance activities, including facility inspections, environmental monitoring checks, and audits of equipment maintenance and GMP practices to support continuous audit readiness.
- Complete all assigned training on SOPs and job-related tasks in a timely manner.
- Stay current with industry trends, updates to regulatory requirements, and emerging quality standards.
- Perform all other activities as assigned by Manager
Experience:
- 1–3+ years of experience in pharmaceutical quality assurance, regulatory affairs, or GMP auditing.
- Prior experience in providing on-the-floor quality oversight and conducting inspections or working in a regulated pharmaceutical environment preferred.
Skills:
- In-depth knowledge of GMP, GDP, GLP, and relevant international regulations (FDA, EMA).
- Strong analytical, attention to detail investigative, and problem-solving skills.
- Excellent communication (written and verbal) and interpersonal skills.
- Proficiency in MS Office and quality management systems (QMS).
- Ability to travel to facilities for inspections (as required).
Quality Assurance Inspector

Posted 7 days ago
Job Viewed
Job Description
PDS Tech Commercial is hiring a detail-oriented **QA Inspector** to join our client's manufacturing team in **Spring City, PA** . In this critical role, you'll ensure every product meets strict quality standards and specifications. This is a **temp-to-hire (3-month)** opportunity with strong potential for long-term growth and stability.
+ **Pay** = $20-25/hour
+ **Shift** = 1st shift
**What You'll Be Doing**
You'll be the frontline of quality assurance, performing key inspections and audits across the production process. Responsibilities include:
+ Conducting first-piece, in-process, and final inspections
+ Executing Layered Process Audits (LPAs)
+ Using precision tools (micrometers, calipers, thread gauges, height stands) to measure and inspect parts
+ Performing random and 100% inspections as required - recording results
+ Supporting ISO 9001 internal audits and the company's quality management system
+ Maintaining calibration schedules and quality records
**Qualifications - What You Bring to the Table**
**Required:**
+ High school diploma or GED
+ Minimum 2 years of QA experience in a manufacturing environment
+ Proficiency in reading blueprints and using inspection tools
+ Basic computer skills (Microsoft Office)
+ Strong attention to detail and communication skills
+ Ability to work in a hands-on, physical role
**Preferred:**
+ Experience with ERP systems (Oracle a plus)
+ Prior forklift operation experience
**Why Join Us?**
At PDS Tech Commercial, we connect talented professionals with leading employers who value precision, skill, and reliability. When you join us:
+ You're part of a team where **quality is not just a goal - it's the standard**
+ You'll work in an environment that encourages growth and **offers the potential for long-term employment**
+ Enjoy a consistent, daytime schedule that promotes **work-life balance**
+ Access support from a staffing partner with over **50 years of industry expertise**
**Ready to Elevate Your Career in Quality?**
Apply now to become a **QA Inspector** with PDS Tech Commercial in Spring City, PA. Take the next step toward a future built on excellence.
**Submit your application today - your next opportunity is waiting.**
**Pay Details:** $0.00 to 25.00 per hour
Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.
Equal Opportunity Employer/Veterans/Disabled
To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:
+ The California Fair Chance Act
+ Los Angeles City Fair Chance Ordinance
+ Los Angeles County Fair Chance Ordinance for Employers
+ San Francisco Fair Chance Ordinance
**Massachusetts Candidates Only:** It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
Quality Assurance Analyst
Posted 14 days ago
Job Viewed
Job Description
Responsibilities:
- Conduct thorough testing of Salesforce Marketing Cloud components, including dynamic content and various studios and builders.
- Perform validation of Salesforce Data Cloud functionalities such as identity resolution, segmentation, activations, and unified individual reconciliation.
- Identify, document, and track defects or issues discovered during testing, and collaborate with developers to resolve them efficiently.
- Ensure data quality and accuracy within Salesforce Marketing Cloud and Data Cloud platforms, including integration and management processes.
- Develop and maintain comprehensive documentation for testing processes, test cases, and resolutions to defects.
- Create detailed test plans, test cases, and scripts based on project specifications and requirements.
- Analyze testing outcomes to identify opportunities for process improvements, tools, and methodologies.
- Partner with architects, designers, and marketing teams to ensure the quality and effectiveness of marketing campaigns and data workflows. Requirements - Hands-on experience with Salesforce Marketing Cloud, including its various studios and builders.
- Familiarity with diverse testing approaches such as functional, regression, and performance testing.
- Strong understanding of data management principles and practices within Salesforce Marketing Cloud and Data Cloud.
- Proven ability to analyze complex data, identify issues, and implement effective solutions.
- Salesforce Marketing Cloud and Data Cloud certifications are highly preferred.
- Experience working within Agile environments and familiarity with tools like Jira.
- Excellent problem-solving and analytical skills.
- Strong communication skills with the ability to collaborate effectively with technical and non-technical stakeholders. Technology Doesn't Change the World, People Do.®
Robert Half is the world's first and largest specialized talent solutions firm that connects highly qualified job seekers to opportunities at great companies. We offer contract, temporary and permanent placement solutions for finance and accounting, technology, marketing and creative, legal, and administrative and customer support roles.
Robert Half works to put you in the best position to succeed. We provide access to top jobs, competitive compensation and benefits, and free online training. Stay on top of every opportunity - whenever you choose - even on the go. Download the Robert Half app ( and get 1-tap apply, notifications of AI-matched jobs, and much more.
All applicants applying for U.S. job openings must be legally authorized to work in the United States. Benefits are available to contract/temporary professionals, including medical, vision, dental, and life and disability insurance. Hired contract/temporary professionals are also eligible to enroll in our company 401(k) plan. Visit roberthalf.gobenefits.net for more information.
© 2025 Robert Half. An Equal Opportunity Employer. M/F/Disability/Veterans. By clicking "Apply Now," you're agreeing to Robert Half's Terms of Use ( .
Quality Assurance Analyst

Posted 16 days ago
Job Viewed
Job Description
- Develop and maintain detailed test scripts and test cases based on new and evolving website functionality.
- Execute test cases including end-to-end testing to validate functionality, usability, integration, and cross-browser compatibility.
- Log bugs and issues clearly and consistently within Jira, including steps to reproduce and indicating severity for all bug prioritization.
- Monitor Jira to track bug resolution progress and retesting activities.
- Collaborate closely with development teams to ensure timely fixes and verify issue resolution.
- Establish and document a repeatable testing workflow: test → log → resolve → retest → ready for business test → close.
- Perform smoke/sanity testing for initial build validation.
- Responsible and accountable for system and regression testing to validate system integrity after code changes.
- Serve as a consultant with Compliance Testing and Security Testing.
- Remain responsive with System testing and Regression testing updates resulting from changes with unit testing and disaster recovery testing.
- Support User Acceptance Testing (UAT) processes and coordinate with business testers as needed.
- Create and maintain test documentation and QA metrics to communicate status and risks.
- Ensure test coverage across supported browsers and devices to maintain consistent user experience.
- Coordinate and lead bug management with vendors and AD project team member with input from Product Owner and IT.
- Fulfill Quality Assurance responsibilities through Implementation including warranty.
- Participate in daily stand up and report on bug status and escalate blockers/concerns to PM and IT Manager.
Qualifications:
- Bachelor's degree in Information Systems, Computer Science, or related field, or equivalent experience.
- 3+ years of experience in website quality assurance or software testing roles.
- Strong understanding of the software development lifecycle and QA methodologies.
- Experience using Jira or similar issue tracking tools.
- Detail-oriented with strong analytical and troubleshooting skills.
- Excellent written and verbal communication skills.
- Ability to work independently and collaboratively in a fast-paced project environment.
- Familiarity with content management systems such as Drupal is a plus.
- Experience in Agile/Scrum environments is preferred.
Knowledge, Skills, and Abilities:
- Strong understanding of web technologies (HTML, CSS, JavaScript) to help identify front-end issues and better communicate with developers.
- Experience with Drupal CMS or other content management systems to understand site structure and admin workflows.
- Familiarity with cross-browser and responsive design testing tools.
- Knowledge of QA tools and test case management systems.
- Understanding of software testing principles including functional, regression, smoke, and UAT testing.
- Ability to create and optimize test documentation to track cases, issues, and retesting outcomes.
- Experience in Agile development environments, including participation in sprint planning and retrospectives.
- Clear and concise communication skills to effectively report bugs and collaborate with cross-functional teams. Requirements Quality Assurance, Software Quality Assurance, JIRA, Drupal, Manual Test Scripts, Manual Testing, Automated Test Scripts Technology Doesn't Change the World, People Do.®
Robert Half is the world's first and largest specialized talent solutions firm that connects highly qualified job seekers to opportunities at great companies. We offer contract, temporary and permanent placement solutions for finance and accounting, technology, marketing and creative, legal, and administrative and customer support roles.
Robert Half works to put you in the best position to succeed. We provide access to top jobs, competitive compensation and benefits, and free online training. Stay on top of every opportunity - whenever you choose - even on the go. Download the Robert Half app ( and get 1-tap apply, notifications of AI-matched jobs, and much more.
All applicants applying for U.S. job openings must be legally authorized to work in the United States. Benefits are available to contract/temporary professionals, including medical, vision, dental, and life and disability insurance. Hired contract/temporary professionals are also eligible to enroll in our company 401(k) plan. Visit roberthalf.gobenefits.net for more information.
© 2025 Robert Half. An Equal Opportunity Employer. M/F/Disability/Veterans. By clicking "Apply Now," you're agreeing to Robert Half's Terms of Use ( .
Quality Assurance Inspector
Posted today
Job Viewed
Job Description
Quality Operations Inspector -I
Position Summary
The Quality Assurance Inspector is responsible for providing on-the-floor quality oversight and support to ensure the compliance of manufacturing, packaging, labeling, and distribution operations with Piramal Standard Operating Procedures (SOPs) and applicable regulatory requirements. This includes adherence to Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), Data Integrity principles, and FDA regulations. The inspector plays a critical role in maintaining product quality, safety, efficacy, and regulatory compliance across operations.
Key Responsibilities
- Issue batch records in alignment with the production schedule to support timely manufacturing activities and Perform potency calculations as applicable.
- Conduct line clearance and batch readiness assessments, including verification of concurrent documentation, equipment status, and preventive maintenance records.
- Review and evaluate Environmental Monitoring (EM) data for compliance with internal standards and regulatory requirements.
- Perform BMS alarms review, acknowledgement and evaluate quality impact. Escalate critical alarms to Management.
- Perform quality oversight for water system releases used in operations.
- Perform raw material Sampling and AQL inspection of finished products.
- Review equipment logbooks and executed batch records to ensure adherence to GDP, GMP, and Data Integrity standards.
- Scan reviewed batch records and upload to share point.
- Prepare batch records and perform first release of batches.
- Perform Raw material reconciliation and investigation.
- Review and approve Calibration activities in ProCal.
- Perform QA review and approval of non-routine workorders in SAP.
- Draft, revise, and review Quality Assurance SOPs and deviation reports to ensure clarity, accuracy, and regulatory alignment.
- Conduct weekly quality surveillance activities, including facility inspections, environmental monitoring checks, and audits of equipment maintenance and GMP practices to support continuous audit readiness.
- Complete all assigned training on SOPs and job-related tasks in a timely manner.
- Stay current with industry trends, updates to regulatory requirements, and emerging quality standards.
- Perform all other activities as assigned by Manager
Experience:
- 1–3+ years of experience in pharmaceutical quality assurance, regulatory affairs, or GMP auditing.
- Prior experience in providing on-the-floor quality oversight and conducting inspections or working in a regulated pharmaceutical environment preferred.
Skills:
- In-depth knowledge of GMP, GDP, GLP, and relevant international regulations (FDA, EMA).
- Strong analytical, attention to detail investigative, and problem-solving skills.
- Excellent communication (written and verbal) and interpersonal skills.
- Proficiency in MS Office and quality management systems (QMS).
- Ability to travel to facilities for inspections (as required).
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Lead Quality Assurance Analyst

Posted 1 day ago
Job Viewed
Job Description
A Lead Quality Assurance Analyst to drive quality assurance strategies and ensure the delivery of top-tier software solutions. In this leadership role, you will mentor and advise QA and Senior QA Analysts, manage testing frameworks, and serve as the primary advocate for quality across the organization. This position is ideal for a proactive professional with strong leadership skills and a passion for excellence in software testing.
**A Day In The Life**
+ Lead and mentor QA team members, fostering collaboration, knowledge sharing, and professional development. (25%)
+ Develop and implement comprehensive testing strategies, plans, and frameworks that align with organizational goals. (15%)
+ Oversee all testing activities, including functional, performance, regression, and integration testing. (10%)
+ Collaborate with stakeholders to define quality objectives, timelines, and deliverables. (10%)
+ Implement and maintain automated testing tools and frameworks to improve efficiency and accuracy. (10%)
+ Analyze testing outcomes, track quality metrics, and present actionable insights to leadership. (10%)
+ Identify process improvements and implement best practices for QA methodologies and workflows. (10%)
+ Manage defect tracking, prioritization, and resolution, ensuring timely communication with development teams. (5%)
+ Advocate for quality standards and practices throughout the software development lifecycle. (5%)
**You'll Come With**
+ 10+ years of experience in application development.
+ Expertise in manual and automated testing methodologies, tools, and processes.
+ Proficiency with bug-tracking and test management tools (e.g., JIRA, TestRail) and automated testing tools (e.g., Selenium, Appium).
+ Strong understanding of the software development lifecycle (SDLC) and Agile methodologies.
+ Exceptional analytical, problem-solving, and decision-making skills.
+ Proven ability to manage and prioritize multiple projects in a fast-paced environment.
+ Outstanding leadership, communication, and collaboration abilities.
+ ISTQB or other QA certification.
#LI-TG1
**Come join our team. You're going to like it here!**
You will enjoy competitive wages, flexible hours, and an associate discount. Burlington's benefits package includes medical, dental and vision coverage including life and disability insurance. Full-time associates are also eligible for paid time off, paid holidays and a 401(k) plan. We are a rapidly growing brand and provide a variety of training and development opportunities so our associates can grow with us. Our teams work hard and have fun together! Burlington associates make a difference in the lives of customers, colleagues, and the communities where we live and work every day. Burlington Stores, Inc. is an equal opportunity employer committed to workplace diversity.
Individual pay decisions will be based on a variety of factors, such as but not limited to, qualifications, education, job-related skills, relevant experience, and geographic location.
**Min-Mid** $95,000.00 - $125,000.00
**Posting Number** R
**Location** New Jersey-Edgewater Park
**Address** 4287 Route 130 S
**Zip Code** 08010
**Pay Rate** Salaried
**Career Site Category** Corporate
**Position Category** Information Technology
**Job Type** Full-Time
**Remote Type** Hybrid
**Evergreen** No
Principal, Quality Assurance, GMP

Posted 16 days ago
Job Viewed
Job Description
Requisition ID:
70962
Date:
Sep 20, 2025
Location:
Exton, Pennsylvania, US
Department:
Quality
Description:
**This is a hybrid position (3 days per week) working in our office at Exton, PA. Candidates applying must be residing within a 50-mile commutable distance to the job location.**
At West, we're a dedicated team that is connected by a purpose to improve patient lives that has been at the center of our Company for more than a century. Our story began when Herman O. West solved the problem of supplying penicillin in mass quantities to the US Government during World War 2. Through our work to deliver thousands of life-saving and life-enhancing injectable medicines to millions of patients daily, West's indelible mark on the healthcare industry has just begun. A name started our story. How will yours help write our future?
There's no better place to join an inclusive community of professionals with opportunities for lifelong learning, growth and development. Supported by benefit programs, we empower the physical, mental, emotional and financial health of our team members and their families.
We believe in giving back to help those in need in the communities where we live and work. And are equally committed to creating a healthier environment and planet through our sustainability efforts.
**Job Summary**
The Principal, Quality Assurance, GMP role focuses on ensuring compliance with cGMP standards within the WSS laboratories by identifying gaps, developing solutions, and overseeing their implementation. Collaborating with key stakeholders, the position ensures all improvements align with global quality and laboratory requirements. The role requires providing expert guidance on regulatory and industry standards concerning data integrity, including computer system validation, audit trails, electronic signatures, and data storage and retention.
**Essential Duties and Responsibilities**
+ Responsible to identify gaps, formulate solutions, and drive closure to achieve and maintain compliance with cGMP standards within the WSS laboratories.
+ Partner with key stakeholders to ensure that identified improvements are aligned with strategic global quality and lab requirements.
+ Provide expertise and guidance for regulatory and industry expectations in terms of data integrity requirements: computer system validation, audit trail, electronic signature, data storage and retention.
+ Perform recurring laboratory audits of quality test methods and results per established West procedures to confirm they are globally harmonized with respect to data recording and documentation.
+ Identify and implement meaningful metrics and KPI's to measure and improve WSS laboratory compliance.
+ Provide guidance to QA and WSS Lab during regulatory and client audits on issues related to Data Integrity and Computer System Validation (CSV).
+ Actively engage with the laboratory team to drive the completion of investigations and manage backlog when necessary; regularly analyze data trends to implement improvements and ensure customer expectations are met through effective reporting and communication.
+ Assist the QA Manager by ensuring WSS team members are trained in GMP-relevant topics and ensuring compliance with quality system documents, cGMPs, ISO standards, and FDA regulations.
**Education**
+ Bachelor's Degree and/or Masters in Science Technology or Engineering.
+ Master's Degree preferred
**Work Experience**
+ 8 years of quality-related experience with preferred experience in pharmaceutical and/or medical device industry
+ Expertise of cGMP requirements, ISO standards and FDA regulations
**Preferred Knowledge, Skills and Abilities**
+ Create multifaceted Laboratory procedures on GMP related topics such as data documentation, processes, documentation templates, etc., in alignment with global laboratory strategies.
+ Perform Expert-Level GMP review and approval of global laboratory documentation, i.e. check for compliance of Lab Records to cGMP requirements related to the activities of the global SME group.
+ Expertise of cGMP requirements, ISO standards, FDA regulations, and quality systems such as ISO 13485, ISO 9001, ISO 15378, 21 CFR 820, 21 CFR 11, ISO 14971
+ Working knowledge of various analytical instruments software and integration with LabVantage LIMS, Waters Nugenesis SDMS and Waters Empower desired.
+ Familiarity with MasterControl, SAP and working knowledge of statistical data analysis
+ Able to be aware of all relevant standard operating procedures as per Company policy as they are related to the position covered by this Job Description.
+ Ability to work independently, multi-task and thrive in fast-paced environment.
+ Thorough understanding of validation activities and risk management principles and techniques
+ Fluent in English
+ Excellent written and verbal communication skills
+ Strong problem-solving and critical thinking skills
+ Support and contribute to Lean Sigma programs and activities towards delivery of the set target
+ Able to comply with the company's safety policy at all times
+ Able to comply with the company's quality policy at all times. #LI-AP1 #LI-HYBRID
**Travel Requirements**
10%: Up to 26 business days per year
**Physical Requirements**
Sedentary-Exerting up to 10lbs/4kgs of force occasionally, and/or negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects, including the human body. Sedentary work involves sitting most of the time.
**Additional Requirements**
+ Adaptable to changes in the work environment, able to manage competing demands and deal with frequent change, delays, or unexpected events.
+ Must maintain the ability to work well with others in a variety of situations.
+ Maintain high attention to detail, accuracy, and overall quality of work.
+ Must be able to understand and adhere to established procedures, multi-task, work under time constraints, problem solve, and prioritize.
+ Effectively communicate and interface with various levels internally and with clients.
West embraces diversity and equality of opportunity. We foster an environment where all individuals are safe, treated fairly, valued and respected. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, disability status or other applicable legally protected characteristics. Where permitted by law, employment with West Pharmaceutical Services, Inc. or any of its subsidiary or affiliate companies, is contingent upon the satisfactory completion of post-offer background screening and/or drug screening.
Quality Assurance Inspector (Sellersville)
Posted 1 day ago
Job Viewed
Job Description
Quality Operations Inspector -I
Position Summary
The Quality Assurance Inspector is responsible for providing on-the-floor quality oversight and support to ensure the compliance of manufacturing, packaging, labeling, and distribution operations with Piramal Standard Operating Procedures (SOPs) and applicable regulatory requirements. This includes adherence to Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), Data Integrity principles, and FDA regulations. The inspector plays a critical role in maintaining product quality, safety, efficacy, and regulatory compliance across operations.
Key Responsibilities
- Issue batch records in alignment with the production schedule to support timely manufacturing activities and Perform potency calculations as applicable.
- Conduct line clearance and batch readiness assessments, including verification of concurrent documentation, equipment status, and preventive maintenance records.
- Review and evaluate Environmental Monitoring (EM) data for compliance with internal standards and regulatory requirements.
- Perform BMS alarms review, acknowledgement and evaluate quality impact. Escalate critical alarms to Management.
- Perform quality oversight for water system releases used in operations.
- Perform raw material Sampling and AQL inspection of finished products.
- Review equipment logbooks and executed batch records to ensure adherence to GDP, GMP, and Data Integrity standards.
- Scan reviewed batch records and upload to share point.
- Prepare batch records and perform first release of batches.
- Perform Raw material reconciliation and investigation.
- Review and approve Calibration activities in ProCal.
- Perform QA review and approval of non-routine workorders in SAP.
- Draft, revise, and review Quality Assurance SOPs and deviation reports to ensure clarity, accuracy, and regulatory alignment.
- Conduct weekly quality surveillance activities, including facility inspections, environmental monitoring checks, and audits of equipment maintenance and GMP practices to support continuous audit readiness.
- Complete all assigned training on SOPs and job-related tasks in a timely manner.
- Stay current with industry trends, updates to regulatory requirements, and emerging quality standards.
- Perform all other activities as assigned by Manager
Experience:
- 13+ years of experience in pharmaceutical quality assurance, regulatory affairs, or GMP auditing.
- Prior experience in providing on-the-floor quality oversight and conducting inspections or working in a regulated pharmaceutical environment preferred.
Skills:
- In-depth knowledge of GMP, GDP, GLP, and relevant international regulations (FDA, EMA).
- Strong analytical, attention to detail investigative, and problem-solving skills.
- Excellent communication (written and verbal) and interpersonal skills.
- Proficiency in MS Office and quality management systems (QMS).
- Ability to travel to facilities for inspections (as required).