5,558 Manufacturing Quality jobs in the United States

Description

Quality Operations Specialist is responsible for quality assurance activities related, but not limited to, incoming raw materials & components, manufacturing floor operations (compounding, filling, utilities and warehouse), and suppliers.

Quality assurance activities include leading deviation handling, root cause analysis and CAPA development, conducting document reviews to verify effectiveness of procedures and instructions, and providing training and coaching to Quality and Operations on SOP, GMP and root cause analysis.

Issues Resolution/Continuous Improvement

? Identify and review deviations, determine root cause, and develop CAPAs in collaboration with Quality, Operations staff and suppliers to address product quality issues and GMP related activities

? Certify CAPA completion and effectiveness

? Escalate critical issues to Quality/Operations leadership as required

? Investigate critical customer and consumer complaints

? Disposition out?of?spec materials, as directed

? Monitor progress against improvement initiatives identified by Quality Engineers, CI and ME

Document Review & Auditing

? Conduct documentation reviews in the plant (production, importation and compounding as applicable) for compliance with existing procedures and instructions, and verify the effectiveness of procedures and instructions versus EL requirements and needs

? Perform final (for importation yearly) review of executed batch and filling records and disposition product

? Initiate, revise and review controlled documentation including procedures, investigations, deviations, and reports.

? Participate in routine GMP audits in the plant

Training/Coaching

? Provide training and coaching to Quality and Operations, on topics such as SOP, GMP and root cause analysis

? Perform other responsibilities, as assigned.

Qualifications

? You have at least a Bachelor's degree or equivalent through experience

? You have a sense of initiative and can work independently as well as in a team

? SAP knowledge is a plus

? Knowledge of GDP is a plus

? You are someone with an eye for detail who values quality

? You have strong verbal and written communication skills

Equal Opportunity Employer

It is Company's policy not to discriminate against any employee or applicant for employment on the basis of race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, marital status, military service and veteran status, physical or mental disability, protected medical condition as defined by applicable state or local law, genetic information, or any other characteristic protected by applicable federal, state, or local laws and ordinances. The Company will endeavor to provide a reasonable accommodation consistent with the law to otherwise qualified employees and prospective employees with a disability and to employees and prospective employees with needs related to their religious observance or practices. Should you wish to apply for this position or any other position with the Company and you believe you require assistance to complete an application or participate in an interview, please contact

• Lead and mentor the QA team, providing guidance and training as needed.

• Develop, implement, and maintain quality assurance protocols and procedures.

• Coordinate product inspections, audits, and quality checks to ensure compliance with internal standards and customer requirements.

• Investigate quality issues, perform root cause analysis, and implement corrective and preventive actions (CAPA).

• Maintain and analyze quality data to identify trends and areas for improvement.

• Collaborate with cross-functional teams including Production, Engineering, and Customer Service to resolve quality concerns.

• Ensure all documentation related to QA processes is accurate, up to date, and audit ready.

• Assist in regulatory compliance and certification processes as applicable.

• Support new product launches by establishing quality standards and testing procedures.

• Promote a culture of quality, accountability, and continuous improvement.

• Work on the line as needed and follow supervisor's direction.

• High school diploma or equivalent required.

• Minimum (3-5) years of experience in a quality assurance role,

• Strong understanding of quality control standards, methodologies, and tools (e.g., 5 Whys, Fishbone Diagram, 8D, etc.).

• Experience with quality systems, audits, and industry-specific standards.

• Excellent problem-solving skills and attention to detail.

• Strong communication and interpersonal skills.

• Basic computer skills; familiarity with Microsoft Office and quality tracking tools.

• Quality-related certification (e.g., Six Sigma, ISO Auditor) is a plus.

• Experience in a manufacturing or production environment.

• Full-time, non-exempt position

• Shift Hours

• Monday - Friday

• 5:00 AM - 1:30 PM

• Some voluntary overtime available

• 100% on-site position

• Duties require standing (except breaks and lunch) throughout working shift for 8 to 12 hours

• Ability to use hands and fingers to operate office equipment (e.g., keyboard, mouse, phone)

• Able to lift 10 lbs. continuously and occasionally lift and/or move up to 45 lbs.

• Able to lift up to and above 50 lbs. with machine assistance

• Frequent walking, grasping, gripping, and fine hand manipulation

• Visual acuity at short distances - able to detect variances in orders and cut marks

• Occasional climbing, stooping, bending and overhead reaching

• Core Benefits:

• Health, dental, and vision offered at reduced rates.

• High-deductible health plan enrollees will receive an annual company contribution towards your HSA

• Life insurance and short-term disability insurance covered at 100%

• Voluntary benefits include accident & critical illness, long-term disability, identity theft insurance

• Paid Time Off : 2 weeks vacation + holidays + floating holidays + sick days

• Employee Assistance Program

• Paid Leave: Paid parental leave for employees who qualify for FMLA

• 401(k): Including company contribution

• Professional Growth : Opportunities for certifications, conferences, and tailored career development plans.

• Compensation Range: $22 - $25/hr

• This range reflects the base pay we reasonably expect to offer for this role. Final compensation will be determined based on experience, skills, and internal equity.

• Annual Bonus: Eligible for an annual bonus, which is discretionary and based on company performance.

Job DescriptionManufacturing Quality Assurance Analyst I, Albuquerque, NMNight ShiftBuild your future at Curia, where our work has the power to save lives!Curia is a global contract development and manufacturing organization (CDMO) with over 30 years of experience partnering with pharmaceutical and biotech companies to provide life-saving treatments to patients. At Curia, we are on a mission to advance our customers' therapies from curiosity to cure and ultimately to improve patients' lives.We proudly offer Generous benefit options (eligible first day of employment) Paid training, vacation and holidays (vacation accrual begins on first day of employment) Career advancement opportunities Education reimbursement 401K program with matching contributions Learning platform And more! Summary:The Manufacturing Quality Assurance (MQA) Analyst I role is an entry-level, developmental position. The MQA Analyst I will collaborate with the manufacturing team to provide support in process oversight and first-level decision-making activities. A successful candidate will exhibit a strong safety-focused quality mindset, a capacity for critical thinking, and an aptitude for understanding written SOPs. The MQA Analyst I must communicate effectively during collaborations with production partners and escalate issues urgently to facilitate timely decisions on the path forward. The MQA Analyst I will routinely work collaboratively with management, frontline manufacturing and support group technicians, as well as with senior members of the MQA OTF team.Responsibilities Perform daily audits Perform room inspections Review documentation Communicate effectively Collaborate intra and interdepartmentally Read/interpret SOPs to ensure compliance Maintain up to date trainings Other duties as assignedQualifications High school diploma or general education degree (GED) FDA manufacturing regulated industry experience in an aseptic manufacturing environment, preferred Operations or quality assurance in any industry, preferredOther Qualifications: Must pass a background check Must pass a drug screen May be required to pass Occupational Health Screening Must pass pre-employment assessment Must be able to obtain and maintain gowning certification Must be able to obtain and maintain media qualification Must be able to wear a respirator Education, experience, location and tenure may be considered along with internal equity when job offers are extended.Physical Demands:The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.The essential physical demands will vary for each Curia position. All positions may require regular or occasional lifting, pushing and pulling up to 10 pounds, frequently; up to 25 pounds occasionally; and up to 50 pounds infrequently. Additionally, all positions entail regular sitting, standing and reaching, with some roles requiring prolonged periods of time for each activity. Visual acuity, both close and distant, along with depth perception is necessary in each role, with or without corrective lenses. Please note that employees are prohibited from wearing contact lenses in work areas with exposure to cleaning agents. Hand and finger dexterity are integral to all positions, with specific activities varying from typing to manipulating maintenance tools or operating keypads, switches, and buttons. Occasional stooping, kneeling, twisting, crouching, crawling and balancing are also part of each position's physical requirements. Certain roles may involve climbing and working at elevated heights as well.Work Environment:The work environment characteristics, described below, are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.The working environments will vary for each Curia position. The employee may be required to work in an office, manufacturing, or warehouse environment. The office environment is designed for comfort and productivity, with room temperature settings maintained for optimal working conditions. It is common to hear conversational noise in the background. The pharmaceutical manufacturing environment is sterile. Therefore, aseptic gowning is required. Personal protective equipment (nitrile gloves, clean room socks, face-shields, safety glasses, aprons, steel-toed shoes and powered air purifying respirators) is necessary, depending upon the task at hand. The employee may be exposed to wet and/or humid conditions, confined areas, and refrigerator or freezer temperatures when working in a sterile environment. The warehouse environment is typically set at a controlled temperature but the employee may be exposed to refrigerator or freezer temperatures when retrieving materials. Some positions may occasionally be exposed to moving mechanical parts, elevated heights, airborne particles, electrical activities and vibration. In addition, some positions may work with or be exposed to, compressed gases and must wear ear protection. All environments may be subject to working with or being exposed to cleaning agents. We do not accept unsolicited assistance from any headhunters or recruitment firms for any of our job openings. All resumes or profiles submitted by search firms to any employee at Curia, in any form without a valid, signed search agreement by an authorized signatory in place for the specific position, approved by Talent Acquisition, will be deemed the sole property of Curia. No fee will be paid in the event the candidate is hired by Curia because of the unsolicited referral.All interested applicants must apply online. Please be aware of scammers. Curia will only send offer letters and requests for sensitive personal information from a curiaglobal.com email address. Curia is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Curia is an E-Verify employer.#LI-MM2

Overview Manufacturing Quality Assurance (QA) Lead Boulder, CO About Us At StickerGiant , every sticker has a story. We are a Boulder, Colorado-based eCommerce company that makes custom stickers and product labels for small businesses and organizations. Founded over 20 years ago, StickerGiant pioneered online sticker sales and continues to set the industry standard. Our mission is simple: deliver high-quality products, fast service, and unparalleled customer service. We are guided by our core values: Customer Focus, Growth Mindset, Execution, Trust, and Accountability. We celebrate diversity in all its forms, creating an inclusive environment where everyone thrives. Join us in turning creativity into reality, one sticker at a time! StickerGiant is proudly backed by Ares Management, a top private equity firm. Role Overview The QA Lead is responsible for overseeing quality assurance processes to ensure that products and services meet established standards of quality, including reliability, usability, and performance. The QA Lead will supervise QA team members, coordinate testing and inspection processes, support continuous improvement initiatives, and act as the main point of contact for quality-related issues across departments What You’ll Do Lead and mentor the QA team, providing guidance and training as needed. Develop, implement, and maintain quality assurance protocols and procedures. Coordinate product inspections, audits, and quality checks to ensure compliance with internal standards and customer requirements. Investigate quality issues, perform root cause analysis, and implement corrective and preventive actions (CAPA). Maintain and analyze quality data to identify trends and areas for improvement. Collaborate with cross-functional teams including Production, Engineering, and Customer Service to resolve quality concerns. Ensure all documentation related to QA processes is accurate, up to date, and audit ready. Assist in regulatory compliance and certification processes as applicable. Support new product launches by establishing quality standards and testing procedures. Promote a culture of quality, accountability, and continuous improvement. Work on the line as needed and follow supervisor's direction. What You Bring High school diploma or equivalent required. Minimum (3–5) years of experience in a quality assurance role, Strong understanding of quality control standards, methodologies, and tools (e.g., 5 Whys, Fishbone Diagram, 8D, etc.). Experience with quality systems, audits, and industry-specific standards. Excellent problem-solving skills and attention to detail. Strong communication and interpersonal skills. Basic computer skills; familiarity with Microsoft Office and quality tracking tools. Additional Qualifications and Skills Quality-related certification (e.g., Six Sigma, ISO Auditor) is a plus. Experience in a manufacturing or production environment. Position Schedule Full-time, non-exempt position Shift Hours Monday - Friday 5:00 AM - 1:30 PM Some voluntary overtime available 100% on-site position Physical Requirements Duties require standing (except breaks and lunch) throughout working shift for 8 to 12 hours Ability to use hands and fingers to operate office equipment (e.g., keyboard, mouse, phone) Able to lift 10 lbs. continuously and occasionally lift and/or move up to 45 lbs. Able to lift up to and above 50 lbs. with machine assistance Frequent walking, grasping, gripping, and fine hand manipulation Visual acuity at short distances - able to detect variances in orders and cut marks Occasional climbing, stooping, bending and overhead reaching Why StickerGiant? Core Benefits: Health, dental, and vision offered at reduced rates. High-deductible health plan enrollees will receive an annual company contribution towards your HSA Life insurance and short-term disability insurance covered at 100% Voluntary benefits include accident & critical illness, long-term disability, identity theft insurance Paid Time Off : 2 weeks vacation + holidays + floating holidays + sick days Employee Assistance Program Paid Leave: Paid parental leave for employees who qualify for FMLA 401(k): StickerGiant contributes 5% as follows: a guaranteed 3% contribution + additional match up to 2% of your contribution Professional Growth : Opportunities for certifications, conferences, and tailored career development plans. Compensation Range: $22 - $25/hr This range reflects the base pay we reasonably expect to offer for this role. Final compensation will be determined based on experience, skills, and internal equity. Annual Bonus: Eligible for an annual bonus, which is discretionary and based on company performance. Ready to make an impact? Join our team and be part of a company that is redefining the eCommerce industry—one sticker at a time. We care a great deal about creating an environment where all Giants can bring their whole selves to work and to provide all candidates with an equitable, inclusive, and accessible recruitment process in alignment with our values. At StickerGiant, we provide Equal Employment Opportunity (EEO) to all persons regardless of age, race, national origin, citizenship status, political opinion, social group, ethnic origin, marital status, union affiliation, union sympathy, physical or mental disability, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. This policy applies to all conditions of employment including recruitment, hiring, promotion, termination, leaves of absence, compensation, and training. If you prefer accommodation during the recruiting process, or you have feedback about your candidate experience at StickerGiant, please contact the People+Culture team. Applications will be accepted through: 5/20/2025 #J-18808-Ljbffr