Quality Systems Specialist II - GMP & Compliance
LSNE Contract Manufacturing
PCI Pharma Services is seeking a Quality Systems Specialist II to advance complex QMS activities and drive timely progression of records and improvement initiatives. The role collaborates with process owners and cross-functional teams to ensure records are complete, compliant, and well-resolved. The position requires limited supervision, escalation when needed, and contributing to training and process improvements, with a focus on audit readiness and regulatory compliance. #J-18808-Ljbffr LSNE Contract Manufacturing
- PCI Pharma Services is seeking a Quality Systems Specialist II to advance QMS records and drive improvement initiatives across cross-functional teams. You will support deviations, CAPAs, change controls, and audits while ensuring records are complete and compliant. The...Suggested
$76k - $85.5k
...shape the future of PCI. Summary: The Quality Systems Specialist II performs increasingly complex Quality... ...completeness, accuracy, procedural compliance, and appropriate supporting evidence.... ...industry. Demonstrated knowledge of GMP regulations and quality-system requirements...SuggestedFull timeContract workWork experience placementFlexible hoursDay shift- Innoflight LLC in San Diego, CA seeks a Quality Specialist II to ensure aerospace products meet strict quality, reliability, and compliance standards. You will review EIDPs, perform inspections, and drive continuous improvement across Quality, Engineering, Manufacturing...Suggested
- Innoflight in San Diego seeks a Quality Specialist II to ensure aerospace products meet stringent quality, reliability, and compliance standards. You will review documentation, perform inspections, investigate issues, and support corrective actions, working across Quality...Suggested
- Wondfo USA is seeking a Quality Assurance Specialist to help ensure medical devices... ...supports quality management systems, R&D and design control... ...releases, document control and compliance efforts. Key duties include... ...with manufacturing, GMP record review, and management...Suggested
- ...internal audits of GxP processes (e.g., GMP manufacturing, QC, validation,... ...sampling strategies aligned with risk and compliance priorities. Document findings clearly;... ...Regulatory, Supply Chain, and IT to strengthen quality systems. Maintain audit schedules, metrics,...
- ...Biotherapeutics in San Diego is seeking a Quality Assurance Operations support... ...accuracy, currency, traceability, and compliance of quality records across the organization... ...continuous improvement of the quality system in a GMP environment, with opportunities to contribute...
$60k - $70k
...seeking a #MiracleMaker to join our Quality Assurance team as a QA Operations Specialist II . The QA Operations Specialist... ...of the Quality Management System. Includes the review and approval... ...reports on quality metrics. Ensures compliance with company policies and...Work at officeLocal area- Maravai LifeSciences is seeking a QA Operations Specialist II to maintain and improve the Quality Management System. You will review deviations, NCRs, CAPAs,... ..., change controls, and documentation, ensuring compliance with domestic and international standards including...
- ...seeking a #MiracleMaker to join our Quality Assurance team as a QA Operations Specialist II. The role focuses on maintaining... ...the Quality Management System, reviewing deviations and CAPAs,... ..., and change controls to ensure compliance with ISO 9001:2015. You will lead...
$60k - $70k
...seeking a #MiracleMaker to join our Quality Assurance team as a QA Operations Specialist II . The QA Operations Specialist... ...of the Quality Management System. Includes the review and approval... ...reports on quality metrics. Ensures compliance with company policies and...Contract workFor contractorsFor subcontractorWork at officeLocal area$35 - $50 per hour
...Quality Specialist II GROW WITH US AND STAY EXTRAORDINARY: Launch your career to new heights with... ...radios to cutting-edge cryptographic systems and avionics, everything we build... ...meet rigorous quality, reliability, and compliance standards. You'll work across Quality,...Hourly payWork at officeWork visaFlexible hours- Maravai LifeSciences is hiring a QA Operations Specialist II to maintain and improve the Quality Management System. You will review deviations, NCRs, CAPAs, and supplier... .... You will monitor quality metrics and ensure compliance with ISO 9001:2015 and related standards. The...
$100k - $120k
...families who need them most. The QC Specialist, Analytical supports the quality and compliance of cell therapy programs through... ..., investigations, and quality systems. This role plays a key part in ensuring... ..., complete, and compliant GMP documentation in alignment with data...Work at officeShift work- Capricor Therapeutics is seeking a Quality Auditor to lead and support audits of GMP, QA, and regulatory processes across manufacturing, labs, and supply chain. The role requires 1-2 years of biopharma auditing experience and strong technical writing to document evidence...
$85k - $89k
...Quality Assurance Specialist II – San Diego By Catalent, Inc., a leading global contract... ...projects by ensuring compliance with regulatory requirements... ..., and validation systems. Participate in investigations... ...change actions. Adhere to GMP standards routinely with limited...Contract work$95k - $115k
...seeking an experienced Veeva eQMS Specialist with deep expertise in Veeva... ..., Training, and other Vault Quality modules. This role will partner... ...business needs into scalable system design, ensuring that our Veeva... ...relevant QA experience in a GMP-regulated environment. • Hands...Local area- REVA Medical, Inc. is seeking a Quality Assurance Specialist in San Diego. The role independently owns... ...collaboration with QA staff and Sr. Quality Systems Engineer. The ideal candidate will... ...and eQMS initiatives while ensuring compliance across the quality system. #J-18808-...
- ...inspections. Strong writing and cross-functional collaboration are essential. Requirements include a bachelor's degree in a scientific/technical field, 1-2 years of regulated-audit experience, and knowledge of FDA/ICH/GMP standards. #J-18808-Ljbffr Capricor Therapeutics, Inc.
- Jobtailor is seeking a Quality Compliance Auditor in the San Diego area to perform complex audits, approve DHF/DMR usage, and support ISO 13485 and 21CFR820 compliance across departments. The role requires 5-8 years of quality experience, a biology/chemistry background...
- Capricor Therapeutics is seeking a Quality Assurance Specialist for the Graveyard shift to oversee manufacturing, cryopreservation, and support activities, ensuring cGMP compliance. The ideal candidate will have GMP QA experience and the ability to make independent quality...Night shift
- Grifols is seeking a Quality Inspector III in California to ensure compliance with QSR/ISO and lead audits across internal and external partners. You will review... ...while driving continuous improvement in quality systems. The role requires a BA/BS in a science field, 5-8...
$95k - $124k
...patients.Position Summary:The Senior Quality Assurance Associate - GMP/GDP Auditing is responsible for... ...supporting supplier qualification, compliance oversight, and inspection readiness... ...compliance risks as appropriate.Quality Systems & ComplianceSupport GxP inspection readiness...Full timeContract workTemporary workRemote work$95k - $124k
...staffingfuture.comPosition Summary:The Senior Quality Assurance Associate - GMP/GDP Auditing is responsible for... ...supporting supplier qualification, compliance oversight, and inspection readiness... ...risks as appropriate.Quality Systems & ComplianceSupport GxP inspection readiness...Contract workRemote work- ...Position Overview: The quality assurance specialist assists in ensuring that medical... ..., quality management systems, R&D and design control processes... ..., document control, and compliance efforts. Responsibilities:... ...needed. Review records for GMP compliance and consistency...
- ...Quality Assurance Specialist Job Purpose The Quality Assurance Specialist is... ...defined Quality Management System processes and exercises judgment... ...complex quality and compliance matters. The position serves... .... Conduct or coordinate GMP/QMS and process-specific training...
$25 - $33.5 per hour
..., and follow us on X or LinkedIn . Reporting to the Quality Systems Specialist, the Quality Systems Associate will support document control... ...in accordance with written SOPs. Facilitate/coordinate GMP training for internal employees/departments as required....Hourly payContract workTemporary workH1bWork at office- Conducts compliance audits of difficult & complex documentation and data Approve use of Design... ...Demonstrates working knowledge of Quality Control, Manufacturing and Inventory processes... ...partners Assists in developing quality systems & make recommendations for improvements...
- ...program meetings to provide appropriate QA updates. Maintain and update electronic quality systems, documentation files and folders in accordance with written SOPs. Facilitate/coordinate GMP training for internal employees/departments as required. Identify and facilitate...Contract work
- ...document owners to resolve discrepancies and support cross-functional QA updates. Responsibilities include maintaining electronic quality systems, SOPs, and training coordination, while supporting audits and inspections and adhering to ORIC’s policies and regulatory...
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