QA Operations Specialist
1 week ago
A client of Innova Solutions is immediately hiring for a QA Operations Specialist Position type: Full-time Contract Duration: 12 months Contract Location: Novato, CA 94949 (Hybrid) As a QA Operations Specialist, you will: Summary: The Technical Specialist, Quality Assurance Document Control, reporting to the Head of QA Document Control Novato, responsible for supporting the management of all aspects related to documentation control processes for Quality Assurance and Quality Control and the management of documents in the Veeva Quality Management System. This role requires a working knowledge of Good Manufacturing Practices (GMP), FDA/EMA regulations and will involve collaboration with cross-functional teams to maintain commitment to quality and compliance. Key Responsibilities • Support the development, implementation, maintenance and improvement of the document control system in accordance with FDA, EMA, and other regulatory agency requirements, ensuring that all quality documents are properly and efficiently managed and accessible. • Support the maintenance of QADC hours for Logbooks, corrections, and archive access during business hours with additional hours as needed during audits and inspections. • Ensure all quality documents are properly managed, accessible, and adhere to Good Documentation Practices (GDP). • Support the management of the lifecycle of quality documents, including archiving and retrieval processes. • Support the maintenance of multiple databases such as Logbook trackers, scanned logbooks, notebook trackers, and offsite storage. • Support the management of the backlog of documents in the Veeva system, ensuring periodic review and timely lifecycle management of documents, including Documents to Effective (DtE) and Documents to Approval (DtA). • Collaborate with cross-functional teams to ensure alignment on documentation practices and support quality initiatives. • Ensure right the first time and compliance in all QA Document Control Activities. • Ensure documents are returned promptly and maintain efficient flow of physical documents. • Ensure audit readiness of QADC areas and act as a key point of contact for audits and inspections. • Support the archival of documentation and ensure the QA Document Control room is always audit- ready. • Support training team members as needed. Experience: • Minimum of 3 years within the biotechnology or pharmaceutical industry. • Extensive knowledge of GMP, FDA, EMA, and other regulatory requirements. • Proficient in Veeva EDMS. Education: • BA/BS in life sciences or related field • Advance degree desirable but not required. Other: Thank you Shakir Ahmed () () PAY RANGE AND BENEFITS: Pay Range*: Pay Range: $36 - $39 per hour. *Pay range offered to a successful candidate will be based on several factors, including the candidate's education, work experience, work location, specific job duties, certifications, etc. Benefits: Innova Solutions offers benefits( based on eligibility) that include the following: Medical & pharmacy coverage, Dental/vision insurance, 401(k), Health saving account (HSA) and Flexible spending account (FSA), Life Insurance, Pet Insurance, Short term and Long term Disability, Accident & Critical illness coverage, Pre-paid legal & ID theft protection, Sick time, and other types of paid leaves (as required by law), Employee Assistance Program (EAP).
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QA Operations Specialist
5 days ago
Novato, California, United States Innova Solutions Full time $72,000 - $82,800 per yearA client of Innova Solutions is immediately hiring for aQA Operations SpecialistPosition type: Full-time ContractDuration: 12 months ContractLocation: Novato, CA Hybrid)As aQA Operations Specialist,you will:Summary:The Technical Specialist, Quality Assurance Document Control, reporting to the Head of QA Document Control Novato, responsible for supporting...
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