50 Merck jobs in Harleysville

Job Type

Full-time

Description

Lyons Magnus leads the food industry with creativity and innovation, crafting top-quality products across all manufacturing phases, from raw materials to marketing. With over 2000 diverse items for industrial ingredient and food service sectors, Lyons caters to leading restaurant chains nationally and internationally.

At Lyons, our diverse and talented staff is the heart of our organization. We foster a thriving work environment where employees are engaged in shaping both the company's and their own future.

The Quality Assurance Lead at Lyons Magnus is an entry-level leadership role within the Quality Assurance Department, requiring a deep understanding of product/process quality and food safety systems. The candidate must thrive in a fast-paced manufacturing environment and use techniques including quality and safety guidelines, SOPs, GMPs, HACCP/FSMA regulations, and technical leadership practices. They ensure accurate formulations and safe products, promptly communicating any non-conformance to leadership. In their absence, the Quality Manager or Supervisor will assume these responsibilities.

Hours: 6:00 am - 2:30 pm

Schedule: Monday - Friday

Location: Quakertown, PA

Travel Requirements: None

Work Environment Available: On-site

Core Responsibilities:

• Lead operations technicians to ensure that batches are tested as prescribed in the formulas using proper techniques/SOPs and leveraging best practices to achieve compliance to specifications.
• Assist with all QA requirements for all processing lines including line checks, chemical/physical testing verifications and any other analysis as required by a customers.
• Lead the Food Safety (HACCP) Program, all associated Pre-requisite Programs and ensure compliance to Customer, Federal, State and Local laws and guidelines affecting Food Safety and Quality.
• Support Food Safety Plans by ensuring that CCP and process control checklists are verified daily.
• Execute all finished product testing as prescribed for microbiological and analytical analysis.
• Execute sanitation verification and environmental monitoring swabbing. Conduct investigations and corrective actions where appropriate.
• Verify all performance metrics and SOPs are met or exceeded, with a focus on customer expectations.
• Review and investigate Quality deviations to identify root cause and preventative actions.
• Conduct internal audits to include GMPs and Food Safety.
• Review all Quality and food safety checks, verify for accuracy and completeness within 72 hours of checks being completed or documented. Follow up accordingly with personnel or escalation.
• Ensure all laboratory equipment and supporting operations measuring devices are calibrated, verified as scheduled and functioning as designed. Troubleshoot and or escalate to vendors for effective repair or replacement.
• Continuously improve processes with regards to defect reduction and the support in management of customer complaint investigations and record review.
• Primary owner of root cause analysis and problem solving for all QA/FS related incidents.
• Lead other tasks as prescribed by VP/Director of Quality Assurance.

• Intermediate working knowledge and experience using Microsoft Word, Excel, Access and PowerPoint, MS Dynamics, RedZone, and Tableau software.
• A proven track record of exceptional organizational, planning and overall time management skills in addition to exceptional verbal and written communication.
• A comprehensive understanding of the core competencies of Lyons' manufacturing capabilities, food safety and quality plans.
• Problem solving and critical thinking skills.

• A minimum of a high school diploma or equivalent.
• A minimum of 2 years of successful experience in manufacturing.
• A comprehensive understanding of the core competencies of manufacturing capabilities.

• Test planning: define the overall strategic and tactical objectives for testing software changes at different test levels. Work with developers, project managers and business customers to define the strategy to be used, such as risk-based testing. Test levels include component testing, integration testing, system testing and acceptance testing. Test types include functional testing, non-functional testing, structural ("white-box") testing, confirmation testing and regression testing.
• Test monitoring and control: continuously compare test progress with the plan, adjust the plan and testing activities as necessary, and provide status reports.
• Test analysis and design: transform testing objectives into test conditions and test cases. The test basis includes documented requirements, system architecture, behavior and structure of the software, existing data and data flows. Using structural ("white-box") test techniques, among others, design tests, or provide input into test design by identifying specific test conditions and high-level test cases.
• Test implementation and test execution: develop and prioritize test procedures, set up the test environment and test data, and execute tests. Test changes to the database components of the system under test. Testable components include views, procedures and functions, data conversion and migration programs. Support business customers and others in acceptance testing. Includes identifying database model changes in higher environments (Production and Stage), and making those changes in the lower environments (Test and Development).
• Evaluating exit criteria and reporting, and test closure: asses test execution against the objectives defined in the test plan. Specific tasks and deliverables are defined at the team or project level.
• Identify the necessary test data to support test conditions and test cases as they are defined. Includes data to force error and boundary conditions. Analyze input data, including electronic files, message traffic and variations of user input.
• Provide expected test results, and/or repeatable methods of generating expected test results, based on currently existing data. Includes preparing database queries and guides for testers to use.
• Provide tools and methods to compare expected and actual test results. Includes bi-directional comparisons of database data with electronic files, message streams, and front-end displays.
• Provide high-quality, realistic, fit for purpose and referentially intact test data. Capture end-to-end business processes and the associated data for testing. Subset production data: extract subsets of production data from multiple sources to meet test cases and/or to supply input values for data-driven testing. Create realistic test data sets small enough to support rapid test runs but large enough to accurately reflect the variety of production data.
• Provide test data management. Script the setup of data in the application database to put it in a state that allows a specific set of test cases to be run against it. Script the creation of data files and message streams which require changing variables (usually date or timestamp related) in order to test applications which process them. Script database cleanups.
• Be a specialist in the database layer of systems under test. Understand each database object's purpose and place in the technology stack, the business solutions it supports, and the business rules it encapsulates.

• Assist software development and support teams in software product deployments. Includes deployment/build verification, and identification, analysis and troubleshooting of issues.

• 7+ years of experience as a quality assurance analyst or tester
• Strong customer and business focus
• Strong communication skills
• Understanding of Oracle RDBMS and SQL
• Experience with test driven or behavior driven development practices
• Someone who is energetic and passionate about their work, extremely positive and solution driven
• Someone who has worked on large teams, on projects that have different business owners
• Experience in defining test strategy/approach, test cases
• Strong experience in the testing phase with business personnel, developers and management
• Excellent knowledge of testing methodology (white vs. black box testing, function vs. path testing).
• Experience developing testing artifacts, such as test plans and test cases
• Experience working in multiple Software Development Life Cycle (SDLC) methodologies (Waterfall, Agile)

• Experience in a SOA / Web Services environment
• Experience using iterative development methodologies, specifically SCRUM
• Experience using Xray for Jira or equivalent test management solutions
• Experience using defect tracking tools - Jira preferred
• Experience working hands on with databases - ability to write complex queries and joins
• Experience using automated testing tools - SOAPUI, Cucumber, Selenium
• Scripting experience using applicable languages (such as PL/SQL, Python, UNIX Shell, JavaScript, Perl, Ruby, HTML, DHTML, SOAP, XML, JCL, CICS)
• Experience working with and testing logical data models
• Experience as a software developer or architect

• Under limited supervision and in accordance with all applicable federal, state and local laws/regulations, the Companies' policies, procedures and guidelines, this position.

• Ensure quality and compliance in all my actions

• Attending GMP training on the schedule designated for my role and as appropriate for my role.

• I adhere to strict compliance with procedures applicable to my role.

• Exercise the highest level of integrity in the tasks that I perform.

• In a timely and prompt manner, identify, report, and seek correction for deviations noted in my workplace.

• Embrace a behavior of employee involvement and commitment to doing the job right the first time.

• Ensure employees under your Product of responsibility are trained in required procedures for the execution of their role and maintain current training requirements during the year.

• Promote an environment of employee involvement in the workplace.

• Seek prompt identification, reporting and correction of deviations in the workplace as noted by employees.

• Quality Assurance and Compliance Focus.

• Provides daily 'Shop Floor" QA support to warehouse, bulk manufacturing, and packaging lines.

• Provides leadership support to QA Shop Floor activities including communication of quality events to management.

• Performs or supports activities related to Batch Record Review, Raw Material, Bulk, and Finished Product Releases.

• Provides support to Investigations and/or Investigation Protocols, responsibilities include conducting, writing, reviewing and approvals.

• Performs or supports activities related to Line Audits, Line or Area Cleaning Verifications.

• Participates in design of quality processes and creation/modification/approval of Standard.

• Operating Procedures (SOP's).

• Provides support to Consumer Complaint investigations.

• Provide QA support to various project teams, as needed.

• Actively supports Site metrics, compliance improvement and training initiatives.

• Customer and Performance Improvement Focus.

• Provide support to capturing of site metrics and promote improvement opportunities.

• Facilitate resolution of issues to improve site metrics.

• People & Organization Focus.

• Provides training and direction as needed for new employees.

• Teams with Department members for process feedback and continuous improvement opportunities.

• Represents Quality Assurance in a positive manner.

• Performs other related duties as required.

• 3-5 years Pharmaceutical Industry Quality Experience, with proven success in quality systems/compliance improvement.

• Technical B.S. or B.A. College Degree in Science is preferred.

• Active cGMP Interpretation and Application Experience.

• Demonstrated leadership- possesses the ability to lead a team.

• Strong Organizational Skills.

• Strong Communication/Interpersonal and Facilitation Skills (verbal, written and presentation).

• Problem Solving/Investigation Experience.

• Expertise in Handling Multiple Priorities.

• Process and Systems Experience, especially with SOPs, MBRs, Change Controls, Non-Conformance.

• Investigation Documentation.

• Experience with Liquid Dose processing and packaging technology preferred.

• Validation Experience preferred.

About Day and Zimmermann

No problem is too challenging or complex for Day & Zimmermann Maintenance and Construction (DZMC) because We do what we say! We're here to make life easier for plant owners in the Power, Chemical, and Industrial markets. With our wide-ranging capabilities and long-standing industry experience, we deliver innovative solutions and seamless processes that effectively manage all aspects of the plant life cycle. It's no wonder we're the #1 maintenance services provider in the United States. Come join in on our purpose - We put people to work, we protect American freedoms, and we help our customer's power and improve the world!

We're looking for a full-time, staffDirector, Quality Assurance to join ourDay & Zimmermann team.

Provide Quality Assurance management direction and oversight for QA programs including Nuclear, DOE, DoD, Solar and ISO programs.Manage all QA procedures and verify proper imlementation and address all related issues. Assures through oversight that Quality Assurance activities for the company and venders are defined, planned, implemented and documented in accordance with client, company and industry standards.

• Provide direction and oversight of QA Programs - DOE, DoD, Nuclear, Solar, ISO-9001
• Assures through oversight that Quality Assurance activities for the company and suppliers are defined, planned, implemented and documented in accordance with client, company and industry standards
• Establish and coordinates all audit activities for all business units and project organizations. This includes all vendor and supplier audits and maintain the corporate's Approved Supplier Lists.
• Coordinates activities to ensure that Quality Program budgets, schedules and priorities are met.
• Advises senior quality management and business unit managers of quality related deficiencies, audit findings, regulatory and third party inspection issues. Provides recommended resolution of the identified quality issues

• Analytical ability to grasp key factors from detailed specifications
• Effective verbal communication and report writing skills
• Working knowledge of construction industry Codes and Standards - Welding Processes
• Good leadership capabilities to lead quality initiatives to successful completion
• Basic knowledge of applicable software to compile quality process data. Familiar with the tools, concepts and methodologies of quality management

* College degree or equivalent experience

* 15 years Quality related experience

* Lead Auditor, Auditor Certification

In compliance with this state's pay transparency laws, the salary range for this role is $124,080 - $186,120. This is not a guarantee of compensation or salary, as final offer amount may vary based on factors including but not limited to experience and geographic location. (The specific programs and options available to an employee may vary depending on date of hire, schedule type, and the applicability of collective bargaining agreements).

We care about our employees, and it shows. Our staff receive a competitive salary and a comprehensive benefits package which includes medical/Rx, dental and vision coverage; life, AD&D and disability insurance; flexible spending accounts; 100% paid maternity leave for up to 12 weeks, parental leave, family leave, other paid time off; voluntary benefits and discount programs to meet our employees' individual needs including pet insurance for our furry family members!

To ensure a safe work environment while meeting the physical demands of the job, you must be able to perform the following physical and mental tasks, with or without a reasonable accommodation:

* Visual acuity (e.g., needed to prepare and analyze data, to transcribe documents, to view a computer, to read, to inspect objects, to operate machinery * Balancing (e.g., maintaining equilibrium when walking, climbing, crouching etc.) * Stooping (e.g., bending the spine at the waist) * Walking * Kneeling, crouching or crawling * Manual Dexterity (e.g. picking, pinching, typing, or other working that uses fingers) * Grasping (e.g., use of hand of apply pressure) * Feeling (e.g. perceiving an object's size, shape, texture etc.) * Climbing (e.g. ascending/descending ladders, stair, scaffolding, ramps, pole etc. using feet and legs or hands/arms to climb) * Hearing * Talking * Capacity to think, concentrate and focus over long periods of time * Ability to read/write complex documents in the English language * Capacity to reason and make sound decisions * Capacity to express thoughts orally * Ability to regularly perform all job functions at company's office or work site * Travel required 30%

SO WHAT ARE YOU WAITING FOR? APPLY NOW! Talent Acquisition Partner: Ashley Mitchell

Diversity, Inclusion & Equal Employment Opportunity

Day & Zimmermann is committed to maintaining an inclusive workforce, where employees are hired, retained, compensated and promoted based on their contributions to our Company. Our collective strength is rooted in over a century of diverse employees and businesses, commitment to success, and delivery on promises made. Federal and state Equal Employment Opportunity laws prohibit employment discrimination based on race, color, religion, sex, sexual orientation, age, national origin, citizenship status, veteran status and disability status. Day & Zimmermann is committed to providing an equal opportunity work environment in full compliance with these laws. If you are an individual with a disability and you require an accommodation in the application process, please , and please specify which position you are interested in, including job title and location.

Responsibilities: Under limited supervision and in accordance with all applicable federal, state and local laws/regulations, the Companies' policies, procedures and guidelines, this position. Ensure quality and compliance in all my actions Attending GMP training on the schedule designated for my role and as appropriate for my role. I adhere to strict compliance with procedures applicable to my role. Exercise the highest level of integrity in the tasks that I perform. In a timely and prompt manner, identify, report, and seek correction for deviations noted in my workplace. Embrace a behavior of employee involvement and commitment to doing the job right the first time. Ensure employees under your Product of responsibility are trained in required procedures for the execution of their role and maintain current training requirements during the year. Promote an environment of employee involvement in the workplace. Seek prompt identification, reporting and correction of deviations in the workplace as noted by employees. Quality Assurance and Compliance Focus. Provides daily 'Shop Floor" QA support to warehouse, bulk manufacturing, and packaging lines. Provides leadership support to QA Shop Floor activities including communication of quality events to management. Performs or supports activities related to Batch Record Review, Raw Material, Bulk, and Finished Product Releases. Provides support to Investigations and/or Investigation Protocols, responsibilities include conducting, writing, reviewing and approvals. Performs or supports activities related to Line Audits, Line or Area Cleaning Verifications. Participates in design of quality processes and creation/modification/approval of Standard. Operating Procedures (SOP's). Provides support to Consumer Complaint investigations. Provide QA support to various project teams, as needed. Actively supports Site metrics, compliance improvement and training initiatives. Customer and Performance Improvement Focus. Provide support to capturing of site metrics and promote improvement opportunities. Facilitate resolution of issues to improve site metrics. People & Organization Focus. Provides training and direction as needed for new employees. Teams with Department members for process feedback and continuous improvement opportunities. Represents Quality Assurance in a positive manner. Performs other related duties as required. Requirements: 3-5 years Pharmaceutical Industry Quality Experience, with proven success in quality systems/compliance improvement. Technical B.S. or B.A. College Degree in Science is preferred. Active cGMP Interpretation and Application Experience. Demonstrated leadership- possesses the ability to lead a team. Strong Organizational Skills. Strong Communication/Interpersonal and Facilitation Skills (verbal, written and presentation). Problem Solving/Investigation Experience. Expertise in Handling Multiple Priorities. Process and Systems Experience, especially with SOPs, MBRs, Change Controls, Non-Conformance. Investigation Documentation. Experience with Liquid Dose processing and packaging technology preferred. Validation Experience preferred.

Job Type Full-timeDescriptionLyons Magnus leads the food industry with creativity and innovation, crafting top-quality products across all manufacturing phases, from raw materials to marketing. With over 2000 diverse items for industrial ingredient and food service sectors, Lyons caters to leading restaurant chains nationally and internationally.At Lyons, our diverse and talented staff is the heart of our organization. We foster a thriving work environment where employees are engaged in shaping both the company's and their own future.The Quality Assurance Lead at Lyons Magnus is an entry-level leadership role within the Quality Assurance Department, requiring a deep understanding of product/process quality and food safety systems. The candidate must thrive in a fast-paced manufacturing environment and use techniques including quality and safety guidelines, SOPs, GMPs, HACCP/FSMA regulations, and technical leadership practices. They ensure accurate formulations and safe products, promptly communicating any non-conformance to leadership. In their absence, the Quality Manager or Supervisor will assume these responsibilities.Hours: 6:00 am - 2:30 pmSchedule: Monday - FridayLocation: Quakertown, PATravel Requirements: NoneWork Environment Available: On-siteCore Responsibilities:Lead operations technicians to ensure that batches are tested as prescribed in the formulas using proper techniques/SOPs and leveraging best practices to achieve compliance to specifications.Assist with all QA requirements for all processing lines including line checks, chemical/physical testing verifications and any other analysis as required by a customers.Lead the Food Safety (HACCP) Program, all associated Pre-requisite Programs and ensure compliance to Customer, Federal, State and Local laws and guidelines affecting Food Safety and Quality.Support Food Safety Plans by ensuring that CCP and process control checklists are verified daily.Execute all finished product testing as prescribed for microbiological and analytical analysis.Execute sanitation verification and environmental monitoring swabbing. Conduct investigations and corrective actions where appropriate.Verify all performance metrics and SOPs are met or exceeded, with a focus on customer expectations.Review and investigate Quality deviations to identify root cause and preventative actions.Conduct internal audits to include GMPs and Food Safety.Review all Quality and food safety checks, verify for accuracy and completeness within 72 hours of checks being completed or documented. Follow up accordingly with personnel or escalation.Ensure all laboratory equipment and supporting operations measuring devices are calibrated, verified as scheduled and functioning as designed. Troubleshoot and or escalate to vendors for effective repair or replacement.Continuously improve processes with regards to defect reduction and the support in management of customer complaint investigations and record review.Primary owner of root cause analysis and problem solving for all QA/FS related incidents.Lead other tasks as prescribed by VP/Director of Quality Assurance. RequirementsKnowledge, Skills and Abilities:Intermediate working knowledge and experience using Microsoft Word, Excel, Access and PowerPoint, MS Dynamics, RedZone, and Tableau software.A proven track record of exceptional organizational, planning and overall time management skills in addition to exceptional verbal and written communication.A comprehensive understanding of the core competencies of Lyons' manufacturing capabilities, food safety and quality plans.Problem solving and critical thinking skills.Education and/or Experience:A minimum of a high school diploma or equivalent.A minimum of 2 years of successful experience in manufacturing.A comprehensive understanding of the core competencies of manufacturing capabilities.Additional Information Our compensation program is designed to attract, motivate, and retain the very best people. Lyons Magnus offers a comprehensive benefits plan that include: Health, Dental Insurance, Life Insurance, Long Term Disability, Sec. 125, 401(k) plan, and more. If you meet these requirements and are eager to join a dynamic company poised for further growth, please respond with your cover letter, and salary requirements. To learn more about Lyons Magnus, LLC its products and core values, visit or follow us on Instagram or LinkedIn Lyons Magnus is an Equal Opportunity Employer and with opportunities for advancement. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, protected veteran status, or other protected categories. *This organization participates in E-Verify.