Quality Control Manager

Stokes Pharmacy•Mount Laurel Township, NJ

34d•Hybrid

About The Position

The Quality Control (QC) Manager is responsible for overseeing all Quality Control operations and in-process quality activities associated with the manufacturing of drug products at Epicur Pharma. This position requires experience and knowledge in manufacturing, microbiology, and analytic chemistry; additionally, operating requirements in accordance with cGMP (21 CFR Part 210 and 211). This role ensures testing activities are performed in compliance with current Good Manufacturing Practices (cGMP), FDA regulations, USP standards, and company quality systems. The QC Manager manages laboratory personnel, oversees testing operations, ensures timely release of analytical data, supports investigations, and drives continuous improvement initiatives while maintaining the highest standards of product quality and regulatory compliance.

Requirements

Bachelor’s degree in Biology, Microbiology, Biochemistry, Biotechnology or Chemistry
3+ years of experience directly managing employees including; hiring, performance management, scheduling and conflict resolution required
3-5 years of experience in years of experience in the pharmaceutical industry in drug substance or drug product manufacturing in Quality Control or Quality Assurance
Strong organizational, problem solving, analytical, and management skills
Familiar with GxP, FDA, ICH, and OSHA requirements
Familiar with Microsoft Office applications (Word, Excel, etc.)
Must be capable of wearing all protective wear as required. This includes, but not limited to, mask, gloves, gown, hairnet, safety goggles, etc.
Must have strong organizational skills and exceptional attention to detail
Must exhibit punctuality and low absenteeism
Able to work independently and as part of a team
Able to sit, stand, squat, kneel, reach and walk for prolonged periods of time
May need to lift up to twenty-five (25) pounds on occasion
Must be able to read, write, speak and understand English fluently and have the ability to read and interpret documents such as operating and maintenance instructions and procedure manuals.
Uses addition, subtraction, multiplication and the division of numbers including decimals and fractions when checking of reports, forms, records and comparable data where interpretation is required involving basic skills knowledge.
Must have the ability to solve practical problems and deal with a variety of concrete variables in situations where substantial standardization exists. Must be able to interpret instructions furnished in written, oral, and diagram or schedule form.

Nice To Haves

Workplace Safety experience a plus

Responsibilities

Leads, mentors, and develops employees within Quality Control Department.
Dispositions and approves quality testing/inspection of incoming components, raw materials, finished product, and stability sample.
Leads development of sampling protocols for in-process materials and finished products.
Oversee the testing of raw materials, Active Pharmaceutical Ingredients (APIs), Components, In-process samples and Finished products.
Manage the visual inspection program.
Assist in review and disposition of root cause analysis, risk assessments, and investigation involving manufacturing and quality operations.
Monitor KPIs and identifies CAPA for quality functions.
Conduct and review internal audits of processes, systems, and procedures.
Provide leadership across functional groups to resolve issues relating to product or production quality.
Oversight of method validations for chemistry and microbiology testing methods.
Participation in deviation reports, investigations, and CAPA.
Participates in Annual Product Reviews providing Quality related data and trend reports.
QC review of executed batch record and release of finished drug products.
Research current Quality/Regulatory requirements, as applicable, and leads SOP implementation/revision to assure compliance and continuous improvement of the overall operation.
Ensure all Quality related documents generated at the facility are received by document control at the appropriate time per procedure.
Oversees programs are established maintained for respirator fit test and respirator use protocols to ensure safety of employees and conformance with OSHA and NIOSH regulations.