Quality Assurance Specialist II
Company: Advanced Clinical
Location: Oceanside
Posted on: April 3, 2026
|
|
|
Job Description:
Quality Assurance Specialist II Location: Oceanside, CA
Schedule: Full-time (Monday–Friday; weekend/night work required
during manufacturing campaigns) Department: Quality Assurance
Operations Reports To: Sr. Manager, Quality Assurance Operations
Job Description We are seeking a highly motivated individual to
join our team as a Quality Assurance Specialist II. In this role,
you will be responsible for executing a variety of quality
activities to ensure compliance with applicable quality objectives
and regulatory requirements. This position is based at our
Oceanside, CA site. Key Responsibilities Perform Quality
Assurance-related production and production support activities
Conduct batch record review, line clearance, and provide
on-the-floor QA support Provide QA oversight and approval of
Quality Control activities, including: Method transfers
Certificates of Analysis Stability programs Approve shipments and
oversee product packaging activities Ensure timely assessment and
closure of: Deviations CAPAs Change Controls Laboratory
Investigations Batch and material hold events Communicate lot
disposition and pending issues to management Provide QA oversight
to ensure compliance with GMP standards Perform walkthroughs and
process observations Support document control activities,
including: Archival Updating site training records Assist during
regulatory inspections Ensure products are manufactured in
compliance with regulatory and GMP requirements Escalate issues
that may impact product release timelines Identify compliance risks
and escalate appropriately Generate and update procedures and forms
as needed Perform additional duties as assigned Basic
Qualifications Master’s degree in Biological Sciences or related
field Bachelor’s degree with 2 years of relevant experience
Associate degree with 4 years of relevant experience High School
diploma with 5 years of relevant experience Preferred
Qualifications Background in Quality Control, including: Analytical
testing Virology Microbiology Working knowledge of GMP regulations
(U.S. and EU standards) Strong collaboration and negotiation skills
Proficiency in: Microsoft Word, Excel, PowerPoint Experience with:
Veeva Smartsheet LIMS (Laboratory Information Management Systems)
Excellent verbal and written communication skills Ability to thrive
in a fast-paced, dynamic environment and manage shifting priorities
Benefits Full-time employees are eligible for a comprehensive
benefits package, including: Health coverage Life insurance
Disability insurance 401(k) plan
Keywords: Advanced Clinical, Encinitas , Quality Assurance Specialist II, Science, Research & Development , Oceanside, California
