Quality Assurance Manager Job at Strive Compounding Pharmacy (Fenton)

Quality Assurance Manager

Strive Compounding Pharmacy

Location:
United States , Fenton

Category:
Pharmacy

Contract Type:
Not provided

Salary:

80000.00 - 90000.00 USD / Year

Save Job

Apply Position

Job Description:

The Quality Assurance (QA) Manager provides site-specific quality oversight and ensures full compliance with Strive Pharmacy’s Standard Operating Procedures (SOPs), specifications, and applicable state and federal regulatory standards. This position leads and manages the QA function at the assigned pharmacy location, with responsibility for documentation review, label control, investigations, change control, audits, and product release. The QA Manager supports continuous improvement initiatives and serves as the primary on-site liaison between pharmacy operations, compounding, and corporate Quality leadership.

Job Responsibility:

Supervise the site Quality Assurance team, including task assignment, workload prioritization, timecard management, performance reviews, coaching, and discipline as needed
Lead QA candidate interviews and oversee onboarding, training, and competency development
Conduct routine QA team meetings and cross-department quality huddles
Train QA personnel to ensure proficiency in documentation, review, and compliance expectations
Conduct regular reviews of compounding, production, and cleaning documentation (batch records, cleaning logs, inventory sheets) for accuracy and completeness
Verify and reconcile all labeling to ensure control and accountability
Review temperature monitoring and Building Management System (BMS) alarms to verify timely investigation and resolution
Confirm that product test results meet specifications prior to release
Review documentation for media fill and process validation activities
Approve equipment calibration, preventive maintenance, and certification records to ensure adherence to schedules and standards
Ensure that all documentation follows Good Documentation Practices (GDP) and complies with USP <795>/<797>/<800>/<1163>
Triage and escalate customer complaints into formal quality events when applicable
Review and approve deviation, non-conformance, and CAPA documentation for completeness and adequacy of root-cause analysis
Oversee change control activities, ensuring that proposed changes are properly assessed for quality impact
Collaborate with QA Specialists to document non-compliance events and coordinate third-party testing for particulate or microbial identification when necessary
Review supplier qualification records and verify materials are sourced from compliant, approved vendors
Maintain control of printed and electronic labels and other controlled documents
Ensure proper retention and retrieval of all quality records per Strive retention policy
Lead external audits (regulatory, partner, or client) in partnership with the Pharmacist-in-Charge (PIC)
Conduct internal audits to verify compliance with SOPs, USP standards, and regulatory requirements
Report weekly site quality metrics and trend data to the Director of Quality
Review all documentation submitted to third-party agencies or partners for accuracy and completeness
Report product complaints and adverse drug events to appropriate regulatory agencies in collaboration with corporate QA
Authorized to approve or reject compounded products, raw materials, and components based on quality review and testing results
Authorized to pause or halt operations pending investigation when quality, safety, or compliance risks are identified

Requirements:

High School Diploma or GED
Minimum of five (5) years experience in a quality or manufacturing department within a pharmaceutical, medical device, or allied health science environment
Proven experience in aseptic operations and working in regulated environments
Strong knowledge of pharmaceutical quality assurance practices, including deviation management, CAPA, change control, and documentation review
Ability to analyze and interpret data, identify trends, and recommend preventive actions
Strong organizational, communication, and problem-solving skills
Proficiency with Microsoft Office Suite and quality management systems (QMS)

Nice to have:

Associate’s or higher degree in Biology, Microbiology, Chemistry, or Pharmacy
Prior experience leading a QA team in a compounding or manufacturing environment
Familiarity with 503A or 503B compounding regulations, USP <795>/<797>/<800>, and FDA 21 CFR 210/211
Experience participating in or leading regulatory or partner audits

What we offer:

Employer paid healthcare coverage available after 30 days of employment
Choice of an FSA/HSA
Voucher for new hire scrubs (if applicable)
Parental leave
401(k) plan with matching contributions
Weekends and holidays off
FREE COMPOUNDED MEDS to employees and immediate family members

Additional Information:

Job Posted:
December 12, 2025

Employment Type:

Fulltime

Work Type:

On-site work

Strive Compounding Pharmacy - All Job Offers

Job Link Share:

Quality Assurance Manager

Strive Compounding Pharmacy

Location:
United States , Fenton

Category:
Pharmacy

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Nice to have:

Additional Information:

Job Posted:
December 12, 2025

Looking for more opportunities? Search for other job offers that match your skills and interests.

Similar Jobs for Quality Assurance Manager

Senior Quality Assurance Manager

Operational Risk Management - Quality Assurance Lead - SVP

Manager of Quality Assurance

Manager, Quality Assurance Data

Senior Manager, Quality Assurance & Operations Excellence

Quality Assurance Manager, Customer Success