About the Role: The Quality Control (QC) Manager is responsible for overseeing and executing all QC shop floor activities to ensure compounded sterile preparations (CSPs) meet established quality, safety, and regulatory standards. This role ensures compliance with USP , USP , USP , state board requirements, and FDA guidance applicable to 503A sterile compounding environments. The QC Manager works closely with the Pharmacist in Charge, Quality Assurance, Microbiology, Compounding Operations, and Pharmacy leadership to maintain a robust quality control program that protects patient safety and supports continuous improvement.
You Will:Product Testing & Release- Oversee sampling, testing, and documentation of sterile drug products for sterility, endotoxin, potency, identity, particulate matter, and pH, as applicable.
- Manage coordination with third-party analytical laboratories, including sample submission, data review, and investigation of test abnormalities.
- Review and approve Certificates of Analysis (COAs) and ensure results meet specifications prior to product release.
Environmental & Process Monitoring- Manage quality control shop floor activities during compounding operations to ensure appropriate coverage over all shifts.
- Ensure the quality control team remains compliant with gowning, line clearance, and visual inspection competency assessments and qualifications, along with other required training.
- Provide guidance to quality control team on room clearance, line clearance and Acceptable Quality Level (AQL) inspections
- In collaboration with Microbiology, supervise viable and non-viable environmental monitoring in ISO-classified areas in accordance with USP .
- Oversee personnel monitoring (gloves, gowns, fingertip sampling) and ensure compliance with established frequency and limits.
- Trend environmental monitoring data and implement corrective actions for excursions.
Deviation, OOS, and Investigation Management- Collaborate with Microbiology and Pharmacist in Charge on investigations for out-of-specification (OOS) results, sterility failures, and environmental excursions
- Conduct and document event investigations and root-cause analyses; propose and verify effectiveness of corrective and preventive actions (CAPA).
- Ensure investigations are timely, compliant, and thorough prior to seeking pharmacist approval
Documentation & Record Control- Ensure quality batch record review checklists are completed in accordance with internal processes and procedures.
- Maintain accurate quality records, logs, test results, and retain sample documentation.
- Ensure data integrity principles (ALCOA+) are followed across all QC-related records.
- Support revision and creation of SOPs and work instructions related to QC operations.
Equipment Oversight- Collaborate with the microbiology manager on qualification, calibration, and maintenance of QC instruments (e.g., particle counters, incubators, pH meters, balances).
- Ensure appropriate compounding equipment logs, preventive maintenance, cleaning and calibration files are maintained and up-to-date.
Quality Systems Support- Partner with the Pharmacist in Charge and QA to support audits, mock inspections, and regulatory inspections.
- Participate in risk assessments, change controls, and continuous improvement meetings.
- Support training of pharmacy staff on quality compliance requirements and aseptic principles.
Operational Support- Provide technical and shop floor support to sterile compounding personnel related to testing requirements, sampling, and product specifications.
- Ensure proper handling, storage, and disposal of testing materials, media, and reagents.
- Monitor trends to identify opportunities to enhance sterility assurance and product quality.
You Have:- Bachelor's degree in Chemistry, Microbiology, Biology, Pharmaceutical Sciences, or related field.
- Minimum 3-5 years of QC experience in a sterile compounding, pharmaceutical, or biotech environment.
- Strong knowledge of USP , USP , USP , cGMP, and state pharmacy regulations.
- Experience with laboratory investigations, root-cause analysis, and CAPA processes.
- Demonstrated ability to interpret analytical data and laboratory test results.
- Excellent documentation skills and attention to detail.
Preferred Qualifications- Experience working directly in a 503A compounding pharmacy or 503B outsourcing facility.
- Familiarity with FDA guidance on sterile compounding.
- Supervisory experience or the ability to lead and develop QC staff.
- Experience with LIMS or electronic quality systems.
Core Competencies- Quality-focused decision-making
- Strong problem-solving and analytical ability
- Aseptic knowledge and high attention to detail
- Effective communication and collaboration across pharmacy and quality teams
- Ability to manage multiple priorities in a fast-paced, regulated environment
Our Benefits (there are more but here are some highlights):- Competitive salary & equity compensation for full-time roles
- Unlimited PTO and company holidays
- Comprehensive health benefits including medical, dental & vision, and parental leave
- Employee Stock Purchase Program (ESPP)
- 401k benefits with employer matching contribution
Conditions of Employment:
- This position will require working with Hazardous Drugs (HD) and would require that Personal Protective Equipment (PPE) be worn for the length of working with these drugs. These items would include gloves, respiratory protection, gown and other items as required.
- This position requires medical approval to wear respiratory protection in the form of negative or positive pressure respirators, including N95, full face respirator, SCBA, or Powered Air Purifying Respirator (PAPR).
- Physical exertion required. Including, but not limited to, walking up to 50% of the time, standing up to 100% of the time, squatting and bending up to 20% of the time and lifting up to 80% of the time for up to a twelve-hour shift. Must be able to lift up to 50lbs.
- Due to the risk of reproductive capability in handling or compounding certain Hazardous Drugs (HD) associates must be willing to confirm that they understand the potential risks (teratogenicity, carcinogenicity and reproductive effects) of handling hazardous drugs.
