Quality Assurance Specialist III - Brea, CA

VetJobs; Brea (CA); On-site; USD 91,000 - 101,000; Full time

Job summary

VetJobs seeks a Quality Assurance Specialist to provide real-time QA oversight on the manufacturing floor, ensuring compliance with cGMP and FDA regulations. This on-site role involves batch record review, line clearance, and support for investigations within a pharmaceutical manufacturing environment.

The ideal candidate has a Bachelor’s in chemistry or biology and 8+ years in a cGMP/FDA regulated setting, with strong document editing and SOP-writing capabilities.

Qualifications

• Must have BSc in chemistry or biology or equivalent
• 8+ years in a cGMP/FDA regulated environment such as manufacturing, QC or QA
• Broad knowledge of scientific theories, instrumentation, and analytical techniques
• Thorough knowledge of GMPs and pharmaceutical products
• Experience writing, editing, or reviewing SOPs, work instructions, batch records and guidelines
• Must read English documents such as SOPs and operating manuals

Responsibilities

• Provide QA oversight during manufacturing and warehouse operations.
• Perform aseptic processing audits and quality oversight of facilities, processes and personnel.
• Perform line clearance activities before manufacturing and packaging operations.
• Review and release of raw materials, components, and GMP materials per approved procedures.
• Conduct routine GMP observations of facilities, processes and personnel.
• Monitor production schedules to ensure adequate QA coverage.
• Manage reserve sample inventory, storage, reconciliation and retention.
• Review/approve technical documents including protocols and reports.

Skills

QA oversight

cGMP knowledge

FDA-regulated environment

Documentation/editing

Education

Bachelor’s degree in chemistry or biology

High School/GED

Job description

Job Description

Our organization works with partner companies to source qualified talent for their open roles. The following position is available to Veterans, Transitioning Military, National Guard and Reserve Members, Military Spouses, Wounded Warriors, and their Caregivers.

Unless specifically stated otherwise, this role is "On-Site" at the location detailed in the job post.

Nature and Scope

The Quality Assurance Specialist provides real-time quality oversight and support during manufacturing operations to ensure compliance with current Good Manufacturing Practices (cGMP), regulatory requirements, and internal procedures. This position serves as the primary quality representative on the manufacturing floor and is responsible for quality decision-making, batch record review, line clearance verification, aseptic processing oversight, and support of investigations and quality systems.

Essential Duties and Responsibilities

Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time.

• Provide QA oversight during manufacturing and warehouse operations.
• Gown in support to routinely work at controlled rooms; perform aseptic processing audits; perform quality oversights of facilities, process, and personnel; approve quality deviations.
• Perform line clearance activities before manufacturing and packaging operations.
• Perform QA review and release of raw materials, components, and other GMP materials in accordance with approved procedures.
• Conduct routine facility, process, and personnel GMP observations.
• Monitor production schedules and ensure adequate QA support coverage.
• Manage reserve sample inventory, storage, reconciliation, and retention activities.
• Review and approve technical documents including protocol/report.
• Author/Review/approves IQ/OQ/PQ of instruments Protocols and Reports, calibration reports, maintenance reports, OOTN, discrepancy reports, CAPAs, and CCRs as needed.
• Review/approves batch records, logbooks and other related cGMP documents.
• Perform any other tasks/duties as assigned by management.

Auto req ID

483443BR

Minimum Education Required

High School/GED

Additional Qualifications / Responsibilities

Education Requirements and Qualifications

• Bachelor’s degree in chemistry or biology; or equivalent combination of education and experience.
• 8+ Yrs. experience in a cGMP/FDA regulated environment such as manufacturing/QC or QA.
• Broad knowledge of scientific theories, Instrumentation, and analytical techniques.
• Thorough knowledge of GMPs and pharmaceutical products.
• Working knowledge of all phases of pharmaceutical manufacturing and laboratory operations.
• Expertise with writing, editing, or reviewing documents such as SOPs, work instructions, batch records, guidelines, etc.
• Experience in providing high quality deliverables while meeting business needs.
• Must be able to read documents in Standard English such as Standard Operating Procedures, maintenance schedules and operating manuals.

Physical Environment and Requirements

• Physically able to wear laboratory protective gowning and equipment, including but not limited to gowning, goggles, face shields, respirators, and protective gloves. PPE and Respirators are essential for the health and safety of employees.
• Specific vision requirements include 20/20 near vision (can be corrected with eyeglasses or contacts) and color vision.
• Employees must maintain a clean-shaven appearance each working shift to wear tight-fitting respirators properly.
• Employee must be able to occasionally lift and/or move up to 25 pounds.
• This job operates in a professional office environment.
• This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.
• A large portion of the work will be performed in the plant where the noise may be loud.
• Gown in support to routinely work at controlled rooms are required.

Expected Salary Range

$91,000-$101,000

The salary range, displayed is the minimum and maximum annual salary range of compensation for the role that the employer in good faith believes to be accurate at the time of the posting of an advertisement for the role. Actual compensation for the role will be based on a number of different factors including but not limited to the candidate’s qualifications, education, knowledge, skills and experience.

City*

Brea

State*

California

Job_Category

Operations

Job Code

Manufacturing Manufacturing

Affiliate Sponsor

American Regent

Salary Range

Not Disclosed