QA Specialist II​/III

Pay Rate Low: 39 | Pay Rate High: 58

1 year Contract | Vista, CA | Onsite | Compensation for Level II: $39-$52/hr Level III: $44-58/hr

A growing drug substance manufacturer is seeking a Quality Assurance Specialist to join its QA team. This opening is being filled at one of two levels — Level II or Level III — based on the candidate's experience and demonstrated capabilities.

• Support real-time batch record review, ensuring timely and accurate documentation
• Review and process GMP documentation, including batch production records, validation protocols, and reports
• Perform chromatographic data review (HPLC, UPLC, or GC) in a QA capacity as part of batch disposition
• Manage document control activities, including document change requests (DCR), document change control (DCC), and document revision
• Coordinate and assign training, and maintain training records
• Maintain and review GMP logbooks
• Support internal audits and provide day-to-day GMP guidance to other functions

• Bachelor's degree in a science-related field and a minimum of 2 years' experience in a GMP manufacturing setting, or equivalent combination of education and experience
• Experience with GMP document control and change control
• Experience in an ISO 7/8 controlled environment supporting real-time batch record review

Performs all duties of Level I and Level II, in addition to the following:

• Support real-time batch record review with high accuracy, including usage decisions in electronic batch release systems
• Suggest and implement quality system and SOP improvements using LEAN GMP approaches
• Review and approve GMP documentation, including batch production records, validation protocols, data, and reports
• Review, analyze, and trend data to extract relevant quality insights
• Partner with other functions and sites to close out quality records and investigations (e.g., OOS), and approve documents and changes such as master batch records, analytical procedures, protocols, and specifications
• Recommend and implement new policies and procedures to improve existing processes and products
• Resolve GMP system issues and provide guidance on GMP topics across the organization
• Support quality culture through guidance and training of other departments and sites
• Perform internal GMP audits, drive compliance improvements, and provide compliance guidance across departments and sites
• Take an active or lead role in customer and regulatory authority audits
• Write and revise SOPs and specifications; provide technical assistance on production and quality system documents

• Bachelor's degree in organic chemistry or a related field required (Master's degree preferred); or Bachelor's degree in a science-related field with a minimum of 5 years' experience in a GMP manufacturing setting; or Associate's degree in a science-related field with a minimum of 7 years' experience in a GMP manufacturing setting

This job description is a complete list of all desired skills, but not all are required. #INDBH