Quality Assurance Manager

Job Description

Job Description

Company Overview

Before we opened Strive Pharmacy we were unsatisfied with the current state of the pharmaceutical industry. Most of the current pharmaceuticals only offer a one size fits all approach and often come with unwanted and potentially dangerous side effects. We found that through compounding we can offer a much more personalized solution to medicine.

Through this we have been able to help patients get the results they are seeking for their personal needs. After years of working for corporate chains we took the risk and opened Strive Pharmacy. We are dedicated to providing a better experience for each customer and clinic that we work with. Come see the Strive difference.

Our Mission

We're flipping the script with personal medicine. We strive to interrupt an industry that has been closed to personalized care, accessibility, and nuance for too long. We strive to shift a reactive view of self-care and ignite a proactive baseline-shifting approach to health for all. 'The human element' is our crux and catalyst, driving all that we do, whether we're interacting with patients, providers, or practices. We're here to partner with those ready for a change. More than a compounding pharmacy, we're on a mission to positively disrupt healthcare as we know it. Strive is about more than medicine. Strive is about striving for the personal side of healthcare.

Position Schedule : Monday - Friday, 8 : 00am - 4 : 30pm

Location : Fenton, MO

Salary : $80,000 - $90,000

Position Overview :

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.

Key Responsibilities :

Leadership & Team Oversight

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.

Documentation & Quality Review

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

Quality Systems & Compliance Management

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.

Auditing & Reporting

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.

Authority

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.

Qualifications : Required

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)

Preferred :

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

, and FDA 21 CFR 210 / 211

Experience participating in or leading regulatory or partner audits

Annual Salary

$80,000—$90,000 USD

Benefits / Perks

Strive Pharmacy provides a comprehensive benefits package that encompasses various perks such as employer paid healthcare coverage available after 30 days of employment, the choice of an FSA / HSA, a voucher for new hire scrubs (if applicable), parental leave, a 401(k) plan with matching contributions, and the benefit of weekends and holidays off. FREE COMPOUNDED MEDS to employees and immediate family members.

Culture

At Strive, culture plays a fundamental role in shaping our workplace atmosphere. Beyond our exceptional benefits package, we foster a sense of community. Throughout the year, we arrange various holiday potlucks and festive celebrations. Strive is committed to promoting both personal and professional development, striving for our employees to excel and grow in every aspect of their lives, both within and outside of the workplace.

EEO

Strive Pharmacy is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristics as outlined by federal, state or local laws.

Disclaimer

• Please do not call the pharmacy location with questions about your application or interview. A talent acquisition partner will reach out to you.