GMP QA Specialist II — Batch Records & Investigations
$85k - $89kCatalent Pharma Solutions
Catalent Pharma Solutions is hiring a Quality Assurance Specialist II in San Diego. This critical role focuses on ensuring compliance with regulatory requirements and maintaining quality assurance processes. Candidates must have a high school diploma and significant GMP experience. The anticipated salary range in California is $85,000 to $89,000 annually. Enjoy a positive work environment with numerous employee benefits including comprehensive health coverage, PTO, and opportunities for career growth. #J-18808-Ljbffr Catalent Pharma Solutions
$70.31k - $82k
...seeking a Quality Assurance Associate II to join our team. This role is... ...standards. The position will assist in batch record review, deviation investigations, label issuance, and management of... ...controlled documentation across GLP/GCP/GMP systems. The ideal candidate is...SuggestedWork at office$85k - $89k
Quality Assurance Specialist II Position Summary: Work Schedule: Monday... ...pre and post execution batch record review. Authoring/Updating... ...Validation Systems. Participates in Investigations and deviation writing.... ...change actions. Adhere to GMP standards routinely with limited...SuggestedContract workWork experience placementWorldwideMonday to Friday$85k - $105k
...Packaging, and Labeling Operations Batch Record Review, Product Disposition,... ...: Support Quality Assurance (QA) Batch Record Review, Product... ...and in all situations where GMP Batches are required Manage... ...records (CAPAs, Deviations, Investigations, Product Complaints, Audit...SuggestedFull timeContract workTemporary workRemote workShift work- Peregrine Team is seeking a Quality Assurance Specialist in San Diego to support a growing biotech organization. You will review batch records, support audits, and ensure compliance... ...degree and has 3-5+ years of experience in a GMP-regulated environment, with strong...Suggested
$75k - $95k
...Quality Control Associate II/III, Analytical will... ...analytical testing to support batch disposition, in‑process... ...cultures, document data in GMP‑compliant systems, support investigations, and collaborate cross‑... ...standards, including batch records, lab notebooks, and...SuggestedContract work- ...Job title: QA Associate Location: San... ...be assisted by QA Specialists and Sr.... ...requirements. II. Essential Functions... ...incoming materials for GMP production • Assist... ...Reviews production batch records, logbooks and... ...gathering of data, investigations and deviations are...Temporary workShift work
$90k - $125k
...concept to patient. The QA Operations Specialist will support the... ...point of contact for Batch Disposition, Quality Control and Quality Record escalations and document... ...in initiation, investigation and approval of Deviations... ...of experience in a GMP regulated Biopharmaceutical...Work at officeLocal area$75k - $83k
...Quality Assurance Specialist Location: San Diego... ...an experienced QA professional to... ...and participates in investigations, audits, and process... ...compliance record and commitment to... ...deviation investigations, batch record review,... ...competencies include: GMP compliance and...Full timeContract workCasual workWork at officeWorldwideAfternoon shift$33 per hour
...related tasks in support of GMP production. This role... ...position may work closely with QA Specialists and Senior Specialists.... ...clearance · Review production batch records, logbooks, and related documentation... ...standards · Support investigations, deviations, and data...Hourly payTemporary workLocal areaImmediate startShift work$89.22k - $122.67k
...in their career. As a Quality Specialist, you will be responsible for:... ...Radiopharma. Focusing on GMP Investigations and CAPA’s, change management, batch release and batch record reviews, site Quality audits... ...travel 10% - 25%. Relevant QA experience for 3-5 years in a...Temporary workLocal area$22.5 - $24 per hour
...Approval of Product :Reviews and approves manufacturing Design History Records (DHRs), associated test reports and records and reports... ...devicesExperience with QSRs, QC testing methods and general knowledge of GMP requirements for production.Experience with lot release,...Hourly payLocal areaWork visaFlexible hoursShift workWeekend work- ...Assurance experience in a GMP manufacturing... ...technical skills and QA experience, anticipates... ...Quality Assurance Senior Specialist supports clinical trial... ...regulatory expertise to the investigation and deviation... ...drug material Perform batch record review Participates in...
$90k - $110k
...support the design of a robust, data-informed QA framework for a defined pod(s) and/or... ..., distribution, and frontline adoption. Investigate recurring failures and run root‑cause... ...employment qualified applicants with arrest and conviction records. #J-18808-Ljbffr AffirmWork at officeRemote workFlexible hours$86k - $115k
...Responsibilities Lead and support nonconformance (NC) identification, investigation, and disposition activities, including Material Review Board... ...and approve incoming inspection results and perform final batch record review and disposition to ensure compliance with approved...Work at officeLocal areaFlexible hours$70.3k - $75.93k
...Penn Pharmaceutical Services Ltd is seeking a Quality Assurance Specialist in San Diego, CA. This full-time position supports packaging/... ...operations. Responsibilities include reviewing packaging records, tracking quality metrics, and supporting audits. Candidates should...Full time- ...hiring a Quality Assurance Specialist to support a growing biotech... ...Responsibilities Review and approve batch records, deviations, and change... ...teams Assist with CAPA investigations and root cause analysis Qualifications... ...5+ years of experience in a GMP-regulated environment (...
- Siemens Healthineers is seeking a Quality Specialist in San Diego, CA, responsible for providing quality oversight for the manufacturing... ...compliance, and quality assurance. You will manage GMP investigations, conduct audits, and participate in continuous improvement projects...
$75k - $87k
...and document findings in accordance with GMP and data integrity requirements.... ...notebooks, controlled forms, and electronic records. Support preparation and maintenance of... ...control qualification records. Assist with investigations related to assay performance including...$120k - $150k
...System (QMS), while ensuring compliance to GMP requirements, FDA & ISO standards, and... ...Essential Functions: The Senior QS Specialist II will be expected to support all activities... ...control requirements Strong understanding of record retention Skills & Capabilities:...Work at office$120k - $150k
...Summary: The Senior Quality Systems (QS) Specialist II is responsible for leading the planning,... ...System (QMS) in alignment with GMP, FDA, ISO, and global regulatory requirements... ...control requirements Strong understanding of record retention Skills & Capabilities:...Work at office$75k - $87k
...environments. Responsibilities include executing assays, maintaining control materials, and documenting laboratory work in compliance with GMP. The position offers a salary range of $75,000 - $87,000 annually, reflecting the company's commitment to advancing medical science...$90k - $125k
Abzena in San Diego is looking for a QA Operations Specialist to support operations teams in driving... ...operational excellence. This role will involve batch record review, quality control, and... ...with at least 4 years of experience in a GMP regulated facility. The salary ranges...$70.3k - $75.93k
PCI Pharma Services is looking for a Quality Assurance Specialist in California to support clinical trial packaging, inspection, and quality metrics tracking. The role requires a High School Diploma and 3-5 years of relevant experience. Responsibilities include document...- Tandem Diabetes Care, Inc. is looking for a Quality Assurance Associate II in San Diego, California. This role involves conducting in-process and final inspections of manufacturing goods, ensuring compliance with FDA regulations, and maintaining detailed documentation....
$70.3k - $75.93k
...Summary of Objective The Quality Assurance Specialist will support investigation for clinical trial and packaging/labeling and... ...by reviewing executed packaging records for completeness, accuracy, and compliance to GMP and company procedures. Perform document change...Full timeFlexible hours- Title: QA Specialist I Location: San Diego, California Duration: 6 Months 100% Onsite Job Responsibilities: Responsible... ...solve process-related questions/problems and minor investigations Review device history records Train new employees/Quality Control Technician I...Temporary workWork experience placementWork at officeFlexible hours
$75k - $83k
PolyPeptide in San Diego, CA is seeking a Senior Quality Assurance Specialist to ensure that clinical and commercial products meet regulatory... ...maintain high compliance. The ideal candidate has 5-7 years of QA experience in the pharmaceutical sector and a Bachelor's degree...Full time$94.78k - $128.23k
...QA Sr Specialist Job Locations US-CA-San Diego Requisition ID 2026-35775 Position Type Full Time Position... ...related degree preferred Knowledge, skills & abilities: Batch Testing. Inspection. Nondestructive Testing. Product QA....Full timeContract workTemporary workWork at officeShift work$94.78k - $128.23k
...Bachelor's Degree Discipline/Major: Quality or related degree preferred Knowledge, skills & abilities: Batch Testing. Inspection. Nondestructive Testing. Product QA. Quality Assurance Process. Quality Improvement. Quality Inspection. Quality Management System (QMS)....Contract workTemporary workWork at officeShift work$100k - $120k
...About the role: The Quality Assurance (QA) Specialist is responsible for supporting quality... ...standards such as ISO 9001, GAMP 5, EU GMP Annex 11, and 21 CFR Part 11. The QA... ...CAPAs, change controls, and other quality records. Participate in vendor qualification...Local areaFlexible hours
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