Quality Assurance Specialist
BioTalent
We are partnering with a leading biopharmaceutical manufacturing organization seeking a Quality Assurance Specialist (Lot Disposition) to support batch review, lot release, and quality oversight activities in a cGMP-regulated environment. This position plays a critical role in ensuring manufacturing and quality records are compliant, complete, and ready for product disposition while supporting continuous improvement initiatives and maintaining inspection readiness. Key Responsibilities Review Manufacturing Batch Production Records to ensure accuracy, completeness, and compliance with cGMP requirements. Review manufacturing forms, supporting documentation, and batch history records associated with product manufacturing. Support the release of API batches and production lots. Perform QA review of batch history records and related quality documentation. Review testing documentation generated by Microbiology and Chemistry laboratories. Review and approve controlled documents related to manufacturing processes, equipment, facilities, and utilities. Investigate discrepancies and assist with deviation, excursion, and quality event documentation. Provide Quality oversight and support to internal stakeholders and external customers. Serve as a Quality representative on cross-functional teams and projects. Identify process, procedure, and system improvement opportunities and recommend solutions. Collaborate with departments to ensure review activities are completed efficiently and in compliance with applicable procedures. Generate and maintain quality metrics to support operational performance and continuous improvement initiatives. Maintain a state of inspection readiness and support regulatory compliance activities. Qualifications & Requirements B.S. degree in Biology, Chemistry, Biomedical Engineering, Chemical Engineering, or a related scientific discipline. 2+ years of experience in the biopharmaceutical, biotechnology, or pharmaceutical industry. Knowledge of current Good Manufacturing Practices (cGMP) and quality systems. Wednesday through Saturday, 1:00 PM to 12:00 AM (four 10-hour shifts per week). This position is not eligible for visa sponsorship or support such as H1B, TN, E-3, CPT, OPT, STEM OPT, or employment-based permanent residence processes, now or in the future. #J-18808-Ljbffr BioTalent
$71k - $85k
...challenges, move quickly, and deliver consistently high-quality results. Employees at Forma are expected to take on... ...organization. Requirements Job Overview/Summary The Specialist supports Quality Assurance activities regarding materials management, manufacturing...SuggestedContract workForma Life Sciences
Irvine, CA1 day ago- ...teams work closely across functions to solve complex technical and operational challenges, move quickly, and deliver consistently high-quality results. Employees at Forma are expected to take on meaningful responsibility, collaborate directly with colleagues and clients,...SuggestedContract work
$81.15k - $137.95k
...things happen every day. ICF is seeking a Construction QA/QC Specialist to assist LA County with managing federal disaster recovery... .... The Construction QA/QC Specialist will perform day-to-day quality assurance and quality control activities to support residential construction...SuggestedFull timeContract workFor contractorsWork experience placementWork at officeRemote work$65k - $70k
...Join the team at Prescott’s, Inc. — where quality meets care. Prescott’s is a leading medical device services company, trusted... ...1-2 days per week remote. Join our team as a Quality Assurance Specialist and play a critical role in ensuring the quality, safety, and...SuggestedTemporary workRemote work2 days per week1 day per weekPrescott's, Inc
Costa Mesa, CA1 day ago- ...Quality Assurance Associate Are you meticulous, technically-minded, and committed to high standards? Become a quality assurance associate with a highly flexible schedule. We offer short-term mandates in high-quality manufacturing and distribution, allowing you to apply...SuggestedTemporary workImmediate startFlexible hours
Randstad
Irvine, CA1 day ago $30 - $38 per hour
...Quality Assurance Specialist We are seeking a detail-oriented and compliance driven Quality Assurance (QA) Analyst to join our dynamic and growing team. As part of our startup captive finance company specializing in installment loans for the powersports industry, the...Work at office$80.6k - $98.5k
The Senior Quality Assurance Specialist is responsible for document control and change control in the Yorba Linda site. In addition they shall provide support supplier quality assurance (supplier changes, issue quality notifications and SCARs) as well as support internal...$32.69 - $40.86 per hour
...focused on creating innovative solutions to meet the needs of our clients and improve patient outcomes. Your Role: The Quality Assurance Specialist (Early Phase) is an individual contributor who will solve a variety of issues following cGMP regulations and company standards...Hourly payFull timeMonday to FridayWeekend work$75k - $88k
...Job Type Full-time Description Position Summary The Quality Assurance (QA) Specialist ensures the delivery of high-quality, compliant, and data-driven behavioral health services across Crittenton's programs. This role leads clinical chart audits...Full timeContract workWork at officeCrittenton SoCal
Fullerton, CA5 days ago$90k - $120k
...Job Description Job Description Regulatory Affairs and Quality Assurance Specialist Location: Huntington Beach, CA Compensation: $90,000 - $120,000 annually (depending on experience) About the Role At SprintRay, we are in a super-charged growth mode, constantly...Full timeSprintRay
Huntington Beach, CA10 days ago- ...POSITION SUMMARY: The QA Specialist is responsible for independently conducting thorough review of batch production records and supporting... .... Applies working knowledge of cGMP regulations, SOPs, and quality systems to identify discrepancies, support deviation...Work at office
Pyramid Pharma Services, Inc.
Costa Mesa, CA1 day ago $27 - $33 per hour
...Marketing and Sales to align labeling and product positioning with strategic goals Act as a key liaison with food safety and quality assurance teams at major retail partners to ensure compliance and address product-related inquiries Work closely with the Sales team...Work experience placementLocal areaSamyang America
Brea, CA4 days ago- Join the Clean Energy RevolutionBecome a Underground Civil Quality Control Inspection Specialist at Southern California Edison (SCE) and build a better tomorrow. In this job, you’ll be responsible for ensuring compliance with standards, codes, and specifications through...For contractorsFor subcontractorWork at officeLocal areaRelocation
- We are looking for a QA/QC Specialist to join our team and support the quality assurance and quality control efforts across our construction projects. The main goal of this position is to ensure that all work is completed in accordance with project specifications, company...Full timeFor subcontractorWork at office
KPRS Construction Services, Inc.
Brea, CAmore than 2 months ago - Avid Bioservices in Costa Mesa, CA, is seeking a Quality Assurance Specialist (Early Phase) to ensure cGMP compliance and support manufacturing and release activities. You will maintain inspection readiness, review batch production records, assist investigations, and collaborate...
- GREEN MEADOWS HOME HEALTH CARE INC is seeking a Home Health Quality Assurance (QA) / Coding Specialist to review clinical documentation for Medicare CoPs, state/federal regulations, and agency policies. You will perform ICD-10 coding, OASIS review, chart audits, and quality...
- Prescott's, Inc. is hiring a Quality Assurance Specialist to ensure the safety, quality, and reliability of medical equipment. You will strengthen the Quality Management System, lead nonconformance and CAPA processes, and collaborate across departments to improve efficiency...Remote job
- ...Job Description Description: Job Title: QA & Production Specialist SHIFT: 1PM - 10PM - FULL TIME WITH BENEFITS Role Overview... .... You will be responsible for the hands-on production of high-quality labels while ensuring every batch meets our strict visual and...Full timeShift workAfternoon shift
- ...Our client is seeking a Quality Control Specialist to join their team. As a Quality Control Specialist, you will be part of the Quality Assurance Department supporting inspection, testing, and evaluation of products to ensure they meet established standards. The ideal...Weekly payTemporary workFlexible hours
Experis/Manpower Group
Irvine, CA5 days ago - ...Quality Assurance Auditor Pharmaceutical client in Irvine, CA is searching for a Quality Assurance Auditor to join the Quality Compliance team in Irvine, CA! In this role, you will: Lead internal audits for the site's compliance to GMP regulations, collaborate...
Aequor Inc
Irvine, CA1 day ago - ...Job Description Job Description Role Snapshot Title: Precision Machining Quality Assurance Specialist (Aerospace) Location: Orange County, CA Type: Direct Hire Schedule: Monday–Friday, 5:00 AM start; Saturdays required most weeks (6–8 hours) About...Monday to FridayFlexible hours
$29 - $31 per hour
...Come join our amazing team and work from home! The Loss Mitigation Underwriting Quality Control Specialist primary responsibilities consist of reviewing the accuracy of work performed by the Loss Mitigation Underwriters including the review of approvals, denials, income...Hourly payExtra incomeWork from homeCarrington
Orange, CA2 days ago$24 - $31.63 per hour
...Job Title: Quality Control Auditor Position Summary: Quality Control Auditor role is responsible for conducting in... ...to value ratios alight with underwriting decisions. ~ Quality Assurance: Collaboration with quality control management to help improve...Hourly payWork experience placementWork at officeWork from homeVisa sponsorship2 days per weekKIND LENDING LLC
Santa Ana, CA5 days ago$90k - $107k
...Quality Specialist I Company: B. Braun US Pharmaceutical Manufacturing LLC Job Posting Location: Irvine, California, United States Functional Area: Quality Working Model: Onsite Days of Work: Wednesday, Tuesday, Friday, Thursday...Work at officeRelocationShift workB. Braun Melsungen
Irvine, CA4 days ago- ...corporation serving customers in Clinical Labs, Health care research & Pharmaceutical industry, seeks an accomplished Supplier Quality Specialist. JOB ID: 2277 JOB TITLE: Supplier Quality Specialist DURATION: 12 months + Position Overview: The Supplier Quality Associate...Temporary workLocal areaNight shift
Amerit Consulting
Irvine, CA4 days ago $42.69 - $53.36 per hour
...Senior Specialist, Quality SystemsTustin, CA | Full-TimeHelp Ensure Quality in Life-Saving Biopharmaceuticals Are you passionate about Quality Systems, CAPAs, deviations, GMP compliance, and documentation excellence? We're looking for a Senior Specialist, Quality Systems...Hourly paydisABLEDperson Inc
Santa Ana, CA2 days ago$70k - $80k
...team of compassionate individuals dedicated to purposeful work. Care to join us and make a real impact? Job Overview The Quality Systems Specialist will administrate, coordinate, and execute tasks and activities that contribute to the maintenance and continuous improvement...Work experience placementWork at officeLocal areaWorldwideWork visaRelocation packageFisher & Paykel Healthcare, Inc.
Irvine, CA3 days ago- ...A staffing agency is seeking a Document/Change Control Analyst to support quality initiatives at a medical device company in Irvine, CA. The role requires 5-7 years of experience in quality and/or manufacturing, especially within the medical device sector. Primary responsibilities...Hourly pay
Ledgent Technology
Irvine, CA2 days ago - ...Quality & Compliance SpecialistAmeriPharma is a rapidly growing healthcare company where... ...company evolves.The Quality & Compliance Specialist is responsible for supporting and... ...monitoring organizational compliance and quality assurance efforts, including but not limited to...Work at officeImmediate startMonday to FridayFlexible hours
AmeriPharma
Orange, CA2 days ago $47.59 - $62.5 per hour
...Quality Specialist Anduril Industries is a defense technology company with a mission to transform U.S. and allied military capabilities... ...capture in the process Propose, develop and implement quality assurance policies and procedures and review with the product quality...Hourly payFull timeWork experience placementImmediate start
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