Manufacturing Jobs in Smyrna, TN (Now Hiring) — 128 open — Page 7

Job DetailsJob Location: Smyrna, TN 37167Position Type: Full TimeEducation Level: 4 Year DegreeJob Shift: DayThe 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

QualificationsEducation

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