Find & Apply For Quality Control Analyst Jobs in Santa Monica, California

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 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. SNR8 #IND2

Pay:

$48.00 - $53.00 per hour

Benefits:

401(k) Dental insurance Health insurance Vision insurance Application Question(s):

• Are you a US Citizen or GCH? If on Visa please mention the Visa Status
• Are you ready for background check and drug screen in accordance with the local law and regulations?
• Please confirm your email address and contact number?
• Cube Hub payroll is "Bi-Weekly, we pay every-other-Friday. Are you Comfortable with Bi-Weekly payroll policy?
• What is your Expected Pay Range?

What is a good time to contact you? Are you ok with following Shift (First Shift) Do you have experience in pharmaceutical/biotech QC with laboratory data trending, invalid-result investigations, or control-trending reports? (Yes/No) . Have you used LIMS/KLIMS and statistical tools such as JMP or Minitab to analyze QC data and prepare quality reports, including APR or periodic trending reports? (Yes/No) Do you meet the education and experience requirements for this role, and are you able to work onsite Tuesday-Thursday in Santa Monica initially and subsequently in Thousand Oaks, CA? (Yes/No)

Work Location:

In person