Position Summary The Manager, Quality Assurance is accountable for the performance and compliance of assigned quality systems and operational areas within a regulated contract manufacturing ...
Position Summary The Manager, Quality Assurance is accountable for the performance and compliance of assigned quality systems and operational areas within a regulated contract manufacturing ...
ROLE SUMMARY The QA Specialist II provides advanced quality oversight and exercises judgment in product disposition, investigations, and change control. This role applies specialized knowledge to ...
ROLE SUMMARY The QA Specialist II provides advanced quality oversight and exercises judgment in product disposition, investigations, and change control. This role applies specialized knowledge to ...
ROLE SUMMARY The QA Specialist II provides advanced quality oversight and exercises judgment in product disposition, investigations, and change control. This role applies specialized knowledge to ...
ROLE SUMMARY The QA Specialist II provides advanced quality oversight and exercises judgment in product disposition, investigations, and change control. This role applies specialized knowledge to ...
Position Summary The Manager, Quality Assurance is accountable for the performance and compliance of assigned quality systems and operational areas within a regulated contract manufacturing ...
Position Summary The Manager, Quality Assurance is accountable for the performance and compliance of assigned quality systems and operational areas within a regulated contract manufacturing ...
Quality Assurance Tech II
Saint Louis, MO · On-site
Summary The Quality Assurance Technician II performs a variety of review processes with the intent ... Associates or Bachelor's degree is preferred. Experience: * Minimum of 1-3 years of document review ...
Quality Assurance Tech II
Saint Louis, MO · On-site
Summary The Quality Assurance Technician II performs a variety of review processes with the intent ... Associates or Bachelor's degree is preferred. Experience: * Minimum of 1-3 years of document review ...
Quality Assurance Tech II
Saint Louis, MO · On-site
Summary The Quality Assurance Technician II performs a variety of review processes with the intent ... Associates or Bachelor's degree is preferred. Experience: * Minimum of 1-3 years of document review ...
Quality Assurance Tech II
Saint Louis, MO · On-site
Summary The Quality Assurance Technician II performs a variety of review processes with the intent ... Associates or Bachelor's degree is preferred. Experience: * Minimum of 1-3 years of document review ...
ROLE SUMMARY The QA Specialist II provides advanced quality oversight and exercises judgment in product disposition, investigations, and change control. This role applies specialized knowledge to ...
ROLE SUMMARY The QA Specialist II provides advanced quality oversight and exercises judgment in product disposition, investigations, and change control. This role applies specialized knowledge to ...
This Entry Level Hourly position is located in Bridgeton, MO Under the direction of the Quality Supervisors, provide support for quality system activities to assure conformance to established ...
This Entry Level Hourly position is located in Bridgeton, MO Under the direction of the Quality Supervisors, provide support for quality system activities to assure conformance to established ...
This Entry Level Hourly position is located in Bridgeton, MO Under the direction of the Quality Supervisors, provide support for quality system activities to assure conformance to established ...
This Entry Level Hourly position is located in Bridgeton, MO Under the direction of the Quality Supervisors, provide support for quality system activities to assure conformance to established ...
This Entry Level Hourly position is located in Bridgeton, MO Under the direction of the Quality Supervisors, provide support for quality system activities to assure conformance to established ...
This Entry Level Hourly position is located in Bridgeton, MO Under the direction of the Quality Supervisors, provide support for quality system activities to assure conformance to established ...
Sr. QA/UAT Analyst
Saint Louis, MO · On-site
Job Title Sr. QA/UAT Analyst Summary The Sr. QA/UAT Analyst serves as a senior individual contributor and mentor to the quality assurance and user acceptance testing (UAT) function by helping develop ...
Sr. QA/UAT Analyst
Saint Louis, MO · On-site
Job Title Sr. QA/UAT Analyst Summary The Sr. QA/UAT Analyst serves as a senior individual contributor and mentor to the quality assurance and user acceptance testing (UAT) function by helping develop ...
Job Title Sr. QA/UAT Analyst Summary The Sr. QA/UAT Analyst serves as a senior individual contributor and mentor to the quality assurance and user acceptance testing (UAT) function by helping develop ...
Job Title Sr. QA/UAT Analyst Summary The Sr. QA/UAT Analyst serves as a senior individual contributor and mentor to the quality assurance and user acceptance testing (UAT) function by helping develop ...
Sr. QA/UAT Analyst
Saint Louis, MO · On-site
Job Title Sr. QA/UAT Analyst Summary The Sr. QA/UAT Analyst serves as a senior individual contributor and mentor to the quality assurance and user acceptance testing (UAT) function by helping develop ...
Sr. QA/UAT Analyst
Saint Louis, MO · On-site
Job Title Sr. QA/UAT Analyst Summary The Sr. QA/UAT Analyst serves as a senior individual contributor and mentor to the quality assurance and user acceptance testing (UAT) function by helping develop ...
Sr. QA/UAT Analyst
Saint Louis, MO · On-site
Job Title Sr. QA/UAT Analyst Summary The Sr. QA/UAT Analyst serves as a senior individual contributor and mentor to the quality assurance and user acceptance testing (UAT) function by helping develop ...
Sr. QA/UAT Analyst
Saint Louis, MO · On-site
Job Title Sr. QA/UAT Analyst Summary The Sr. QA/UAT Analyst serves as a senior individual contributor and mentor to the quality assurance and user acceptance testing (UAT) function by helping develop ...
Sr. QA/UAT Analyst
Saint Louis, MO · On-site
Job Title Sr. QA/UAT Analyst Summary The Sr. QA/UAT Analyst serves as a senior individual contributor and mentor to the quality assurance and user acceptance testing (UAT) function by helping develop ...
Sr. QA/UAT Analyst
Saint Louis, MO · On-site
Job Title Sr. QA/UAT Analyst Summary The Sr. QA/UAT Analyst serves as a senior individual contributor and mentor to the quality assurance and user acceptance testing (UAT) function by helping develop ...
QA - Test Analysts
Saint Louis, MO · On-site
Candidates MUST HAVE Cable background with good QA experience Coverage Time : 7:00 am - 10:00 pm CST (Mon-Fri) 8:00 am - 8:00 pm CST (Sat-Sun) Description : * Senior Test Analysts * Provisioning ...
QA - Test Analysts
Saint Louis, MO · On-site
Candidates MUST HAVE Cable background with good QA experience Coverage Time : 7:00 am - 10:00 pm CST (Mon-Fri) 8:00 am - 8:00 pm CST (Sat-Sun) Description : * Senior Test Analysts * Provisioning ...
QA/QC Lab Technician
East Saint Louis, IL · On-site
S. degree in a scientific or technical field is required, or an Associate's degree with equivalent experience. * Experience in QA/QC or process industry laboratory operations. * Familiarity with ...
New
Quick apply
QA/QC Lab Technician
East Saint Louis, IL · On-site
S. degree in a scientific or technical field is required, or an Associate's degree with equivalent experience. * Experience in QA/QC or process industry laboratory operations. * Familiarity with ...
New
QA and Device Specialist
Saint Louis, MO · On-site
$45/hr
QA & Device Specialist (Hardware/Firmware Testing) St. Louis, MO (Onsite Looking for a role with long-term potential? Start as a contract consultant with the opportunity to convert to a full-time ...
QA and Device Specialist
Saint Louis, MO · On-site
$45/hr
QA & Device Specialist (Hardware/Firmware Testing) St. Louis, MO (Onsite Looking for a role with long-term potential? Start as a contract consultant with the opportunity to convert to a full-time ...
QA and Device Specialist
Saint Louis, MO · On-site
$45/hr
QA & Device Specialist (Hardware/Firmware Testing) St. Louis, MO (Onsite Looking for a role with long-term potential? Start as a contract consultant with the opportunity to convert to a full-time ...
QA and Device Specialist
Saint Louis, MO · On-site
$45/hr
QA & Device Specialist (Hardware/Firmware Testing) St. Louis, MO (Onsite Looking for a role with long-term potential? Start as a contract consultant with the opportunity to convert to a full-time ...
QA and Device Specialist
Saint Louis, MO · On-site
QA & Device Specialist (Hardware/Firmware Testing) St. Louis, MO (Onsite Looking for a role with long-term potential? Start as a contract consultant with the opportunity to convert to a full-time ...
Quick apply
QA and Device Specialist
Saint Louis, MO · On-site
QA & Device Specialist (Hardware/Firmware Testing) St. Louis, MO (Onsite Looking for a role with long-term potential? Start as a contract consultant with the opportunity to convert to a full-time ...
Qa Associate information
See South Roxana, IL salary details
$12.28 - $16.50
17% of jobs
$17.89 is the 25th percentile. Wages below this are outliers.
$16.50 - $20.72
24% of jobs
The median wage is $22.83 / hr.
$20.72 - $24.94
18% of jobs
$24.94 - $29.15
15% of jobs
$29.51 is the 75th percentile. Wages above this are outliers.
$29.15 - $33.37
10% of jobs
$33.37 - $37.59
8% of jobs
$37.59 - $41.81
5% of jobs
$41.81 - $46.03
3% of jobs
$46.03 - $50.24
0% of jobs
$50.24 - $54.46
0% of jobs
$54.46 - $58.68
0% of jobs
$12
$27
$58
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Full-time
Re-posted 2 days ago
Job description
The Manager, Quality Assurance is accountable for the performance and compliance of assigned quality systems and operational areas within a regulated contract manufacturing environment. This position provides final quality review and disposition decisions for raw materials, in-process materials, and finished goods, ensuring products meet established specifications, regulatory requirements, and customer expectations.
This role operates with a high degree of autonomy and decision-making authority, serving as a primary Quality leader for the site. The Manager, Quality Assurance is responsible for ensuring effective implementation of cGMP requirements (21 CFR Parts 210/211), maintaining inspection readiness, and supporting a proactive quality culture focused on risk mitigation and continuous improvement.
The position serves as a primary Quality representative for contract manufacturing customers, owning quality communications, documentation, and audit readiness.
Key Responsibilities
Quality System Ownership & Decision Authority
- Own and maintain assigned quality systems, including but not limited to deviations, investigations (OOS/OOT), CAPA, change control, batch record review, and product disposition
- Provide final quality review and release/disposition decisions for materials and finished products
- Exercise independent decision-making authority for routine and non-routine quality events, ensuring compliance with cGMP and customer requirements
- Escalate significant quality risks (e.g., recall risk, critical events) in accordance with established procedures
Manufacturing Quality Oversight
- Provide QA oversight of liquid fill manufacturing operations to ensure compliance with cGMPs, internal procedures, and customer-specific requirements
- Support real-time decision-making on the production floor related to deviations, non-conforming materials, and process issues
- Ensure effective execution of in-process controls and finished product inspection requirements
Contract Manufacturing Quality Leadership
- Serve as the primary Quality representative for assigned contract manufacturing customers
- Lead customer quality discussions, governance meetings, and issue resolution calls independently
- Own all customer quality communications, including:
- Deviations and investigations
- Complaint responses
- Customer notifications and regulatory commitments
- Prepare and review customer-specific documentation, including:
- Questionnaires and technical requests
- Specifications and supporting quality data
- Audit responses and follow-up documentation
- Lead and/or support customer audits, ensuring transparency, professionalism, and inspection readiness
Compliance & Regulatory Oversight
- Ensure compliance with applicable regulatory requirements, including FDA, EPA, DNR, ATF, and OSHA
- Maintain inspection readiness at all times; support and lead regulatory inspections and customer audits
- Ensure adherence to data integrity principles (ALCOA+) across all quality systems and documentation
- Ensure consistent and compliant application of site procedures and quality standards
Investigation & Risk Management
- Lead and approve investigations, including OOS, OOT, deviations, and nonconformances
- Ensure robust root cause analysis and implementation of effective corrective and preventive actions
- Monitor and trend quality data to identify emerging risks and drive proactive improvements
- Apply risk-based decision making consistent with ICH Q9 principles
Validation & Change Control Oversight
- Ensure validation programs comply with regulatory requirements and internal procedures
- Oversee quality impact assessments and approvals within the change control system
- Ensure appropriate evaluation of changes for regulatory, product quality, and customer impact
Leadership & Personnel Management
- Directly supervise and develop quality personnel, including both hourly and salaried employees
- Ensure effective training, qualification, and ongoing development of staff
- Provide performance management, coaching, and leadership to drive a high-performing quality organization
- Foster a culture of accountability, ownership, and continuous improvement
Operational Support & Continuous Improvement
- Partner cross-functionally with Manufacturing, Supply Chain, Engineering, and R&D to resolve quality issues and improve performance
- Drive continuous improvement initiatives to enhance product quality, reduce variability, and improve efficiency
- Support site quality metrics and ensure alignment with business and customer expectations
Qualifications
Education
- Bachelor's degree in Chemistry, Microbiology, Engineering, or related scientific discipline required
Experience
- Minimum 10 years of experience in a regulated industry (OTC drug, pharmaceutical, cosmetic, or similar)
- Minimum 5 years of progressive leadership experience in Quality Assurance or Quality Systems
- Demonstrated experience supporting FDA inspections and customer audits
- Experience in a contract manufacturing environment strongly preferred
Knowledge, Skills, and Abilities
- Strong knowledge of cGMP requirements (21 CFR Parts 210/211) and quality system expectations
- Demonstrated ability to make independent, risk-based quality decisions
- Strong investigation skills, including root cause analysis and CAPA effectiveness
- Excellent technical writing and documentation skills
- Strong communication skills with the ability to interface effectively with customers and all levels of the organization
- Ability to manage multiple priorities in a fast-paced manufacturing environment
- High level of accountability, ownership, and professional judgment
Work Environment
- Work is performed in a combination of office, laboratory-adjacent, and manufacturing environments
- Regular exposure to production areas with varying temperatures, noise levels, and proximity to operating equipment
- Required use of appropriate personal protective equipment (PPE)
Physical Demands
- Regularly required to stand, walk, use hands, and communicate effectively
- Frequently required to move throughout manufacturing and warehouse areas
- Occasional lifting of materials up to 40-50 pounds; frequent handling of light samples (1-5 pounds)
- Requires visual acuity for detailed review of documentation and inspection activities, including ability to distinguish color and fine detail
About Nice-Pak Products
Sourced by ZipRecruiter
Industry
Manufacturing
Company size
501 - 1,000 Employees
Headquarters location
Orangeburg, NY, US
Year founded
1955