You are applying for a position through Medix, a staffing agency. The actual posting represents a position at one of our clients.
Job Summary
Our client is seeking an experienced QA/QC Manager to lead the Quality Control team in ensuring reliable, compliant release and stability testing in the pharmaceutical domain. The role involves overseeing day-to-day lab operations and the effective execution of OOS/OOT investigations, along with developing strong relationships with external laboratories and suppliers.
Key Responsibilities
- Lead the QC team in Analytical & Microbiology to deliver reliable, compliant release and stability testing.
- Own OOS/OOT investigations, lab data integrity, sample/stability programs, and day-to-day lab operations.
- Partner with Sterility Assurance (SA) and execute EM sampling/reading/ID and reports.
- Provide timely, high-quality data enabling QCU disposition decisions.
- Develop and maintain relationships with external laboratories, vendors, and suppliers.
- Investigate and analyze customer complaints and develop corrective action plans.
- Create, assess, monitor, and report quality control metrics.
- Will only have 1 direct report to start.
Qualifications
- 5+ years QC experience in sterile pharmaceuticals or 503B, including 3+ years managing labs/teams.
- Hands-on with USP <71>, <85>, <788> (plus <61>/<62> as applicable) and method validation/transfer.
- Proven OOS/OOT leadership, strong technical writing, and inspection participation.
- Working command of 21 CFR 210/211, Part 11, FDA Aseptic Processing Guidance, and 503B cGMP expectations.
- Gown Qualified for ISO 7/8 (observe ISO 5), support off-hours testing as needed.
- BS Degree preferred.
- Experience with rapid micro/ID, visual inspection defect libraries, ISO 17025 practices, and CCI awareness preferred.
- LIMS administration, chromatography data systems administration, and data-integrity auditing experience preferred.
- ASQ certifications (CQE/CQA) or PDA/ISPE aseptic training preferred.
Benefits
- Paid Sick Leave (Medix provides paid sick leave according to state and local sick leave ordinances).
- Health Benefits / Dental / Vision (Medix offers 6 different health plans: 3 Major Medical Plans, 2 Fixed Indemnity Plans (Standard and Preferred), and 1 Minimum Essential Coverage (MEC) Plan. Eligibility for health benefits is based on verifying that an average of 30 hours per week during the first 4 weeks of the work assignment has been met. If you meet eligibility requirements and take action to enroll, you will be covered no earlier than 60 days into your assignment, depending on plan selection(s)).
- 401k (Eligible on the first 401k open enrollment date following 6 consecutive months on assignment. 401k Open Enrollment dates are 1/1, 4/1, 7/1, and 10/1).
- Short Term Disability Insurance.
- Term Life Insurance Plan.
Required Employment / Compliance Language
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.
*We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable federal, state, and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance (FCIHO), Los Angeles Fair Chance Ordinance for Employers (ULAC), The San Francisco Fair Chance Ordinance (FCO), and the California Fair Chance Act (CFCA).
Medix Overview:
With over 20 years of experience connecting organizations with highly qualified professionals, Medix is a leading provider of workforce solutions for clients and candidates across the healthcare, scientific, technology, and government industries. Through our core purpose of positively impacting lives, we’re dedicated to creating opportunities for job seekers at some of the nation's top companies. As an award-winning career partner, Medix is committed to helping talent find fulfilling and meaningful work because our mission is to help you achieve yours.
Any required state or Joint Commission training is compensated at the state or local minimum wage rate.
*As a job position within our Life Sciences division, a successful completion of a background check may be required as a condition of employment. This requirement is directly related to essential job functions including but not limited to: high-risk work environments (warehouse or industrial areas), high-risk/ high-error job duties that could result in life-threatening injury or death, operation of heavy-duty machinery, working with hazardous chemicals, exposure to other dangerous materials, such as drugs and sharp instruments. Due to these job duties, this position has a significant impact on the business operations and reputation, as well as the safety and well-being of individuals who may be cared for as part of the job position or who may interact with staff or clients.
