Quality Assurance Specialist (Level II / Level III)

Location:

Southern California |

Type:

1-Year Contract, onsite in Vista, CA |

Compensation :

Level II:

$39-$52/hr

Level III:

$44-$58/hr Position Summary A drug substance manufacturer is seeking a Quality Assurance Specialist to support GMP compliance across research, clinical, and commercial-stage production. This opening will be filled at one of two levels — Level II or Level III — based on the candidate's experience and demonstrated capabilities. The role centers on batch record review, GMP documentation processing, and quality system oversight, with the Level III scope extending into advanced technical review, data trending, system improvement, and audit leadership.

LEVEL II

Responsibilities 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 Work within an electronic quality management system to process quality records and approvals Qualifications 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 Working knowledge of an electronic quality management system Strong written and oral communication skills; detail-oriented with strong organizational skills

LEVEL III

Responsibilities Perform all Level I/II duties, plus: Support real-time batch record review with high accuracy, including usage/release decisions within the electronic batch release system Recommend and implement quality system and SOP improvements using

LEAN GMP

principles Review and approve GMP documentation, including batch production records, validation protocols, data, and reports Review, analyze, and trend data to extract actionable insights Partner across 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, specifications, and global specifications Recommend and implement new policies and procedures to strengthen existing systems Resolve GMP system issues and provide guidance on GMP topics across the organization Support and help build quality culture through training and guidance to other departments Conduct internal GMP audits and provide compliance guidance across departments and sites Qualifications Bachelor's degree in organic chemistry or a related field required (Master's preferred); or Bachelor's in a science-related field with 5+ years in a GMP manufacturing setting; or Associate's in a science-related field with 7+ years in a GMP manufacturing setting Certification preferred:

CQA, CQPA

(ASQ), or CQE This job description is a complete list of all desired skills, but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you! #INDBH #LI-DNI