Sr. Quality Control (QC) Specialist

Sr. Quality Control (QC) Specialist
Location: Santa Monica, CA (initially), then Thousand Oaks, CA
Work Arrangement: Hybrid – Onsite Tuesday, Wednesday, and Thursday
Contract Duration: 1 Year
Pay Rate : 53/hr on w2
Job Summary
We are seeking an experienced Senior Quality Control (QC) Specialist to support Product Quality within a pharmaceutical or biotechnology environment. This role will focus on QC data trending, laboratory reporting, continuous improvement, and quality compliance. The successful candidate will collaborate with global and site-based QC subject matter experts and cross-functional teams within Technical Operations.
Key Responsibilities
Execute global reporting controls and invalid result trending programs.
Extract and analyze data from Laboratory Information Management Systems (LIMS) to support reporting requirements.
Lead and coordinate continuous improvement initiatives in partnership with site teams.
Author the Annual Product Review (APR) laboratory section.
Prepare quarterly invalid result trending reports and semiannual control trending reports.
Support laboratory operations with new analytical methods, technologies, and KLIMS implementations.
Assist with new module implementations and the installation of new laboratory capabilities.
Ensure accurate and timely completion of reports in accordance with established procedures.
Collaborate with cross-functional teams to improve processes and operational effectiveness.
Maintain compliance with applicable quality systems, regulatory requirements, and laboratory standards.
Required Qualifications
Master’s degree with 4+ years of experience in pharmaceutical or biotechnology Quality; OR
Bachelor’s degree with 6+ years of experience in pharmaceutical or biotechnology Quality; OR
High school diploma with 10+ years of experience in pharmaceutical or biotechnology Quality.
Experience with QC data trending, laboratory reporting, and quality systems.
Proficiency in statistical tools such as JMP and/or Minitab.
Working knowledge of GMP, GLP, and 21 CFR Parts 11, 210, and 211.
Experience with LIMS and Microsoft Office applications.
Strong written and verbal communication, organizational, and time-management skills.
Ability to manage multiple priorities and meet reporting deadlines.
Preferred Qualifications
Experience in the pharmaceutical or biotechnology industry, particularly cell and gene therapy.
Statistical analysis experience in biologics.
Familiarity with risk management processes.
Experience supporting US and international health authority inspections.
Experience with continuous improvement initiatives and laboratory system implementations.
Ideal Candidate Profile
The ideal candidate will have strong pharmaceutical or biotechnology QC experience, hands-on knowledge of laboratory data trending and reporting, proficiency with LIMS and statistical analysis tools, and a solid understanding of GMP and regulatory compliance.
Contract: 12 months
Work Schedule: Hybrid, with Tuesday–Thursday onsite collaboration days. The role will initially be based in Santa Monica during November, include some remote work, and subsequently return to the Thousand Oaks office