Catalent
Quality Assurance Associate I, Manufacturing
Catalent, San Diego, California, United States, 92189
Overview
Quality Assurance (QA) Associate I, Manufacturing – Catalent San Diego. This role requires familiarity with applicable GMPs and involves evaluating the compliance of documents such as batch records, equipment records, and environmental monitoring records, under supervision. This is a full-time hourly position on the 1st shift (Monday–Friday). Responsibilities
Reviews and dispositions production batch records for product release. Determines if records are compliant with internal and cGMP regulations. Liaison between Manufacturing and QA for executed Batch Record Review and flow of documents. Liaison between QA and clients and communicates with clients regarding Executed Batch Records (EBR) and review status. Tracks status of Executed Batch Records and maintains deadlines for completion of review and corrections. Reviews and approves GMP product labels. Supports GMP manufacturing activities including release of GMP materials, shipment verification, and performance of production audits in a Class 100,000 environment; maintains clinical trial material inventory logs. Other duties as assigned. Qualifications
High school diploma/GED required; Bachelor’s degree desirable. Experience preferred in a GXP manufacturing environment or similar. Highly detail-oriented and organized; able to work independently and as part of a team with a positive attitude. Physical requirements: ability to lift up to 50 lbs and to walk, stand, or sit for extended periods. Pay and Benefits
The annual pay range for this position in California is $55,000 – $65,000. Final salary varies based on experience, skillset, education, and business needs. This range may not reflect positions in other states. Benefits include medical, dental, and vision coverage effective day one of employment; 401(k) with company match; PTO and holidays; tuition reimbursement; wellness programs; and additional employee perks. About Catalent
Catalent is a global leader in drug development and manufacturing, supporting clients from discovery to market with a focus on quality and patient safety. Catalent is an Equal Opportunity Employer. Note: If you require accommodations in the application or hiring process due to a disability, please contact DisabilityAccommodations@catalent.com.
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Quality Assurance (QA) Associate I, Manufacturing – Catalent San Diego. This role requires familiarity with applicable GMPs and involves evaluating the compliance of documents such as batch records, equipment records, and environmental monitoring records, under supervision. This is a full-time hourly position on the 1st shift (Monday–Friday). Responsibilities
Reviews and dispositions production batch records for product release. Determines if records are compliant with internal and cGMP regulations. Liaison between Manufacturing and QA for executed Batch Record Review and flow of documents. Liaison between QA and clients and communicates with clients regarding Executed Batch Records (EBR) and review status. Tracks status of Executed Batch Records and maintains deadlines for completion of review and corrections. Reviews and approves GMP product labels. Supports GMP manufacturing activities including release of GMP materials, shipment verification, and performance of production audits in a Class 100,000 environment; maintains clinical trial material inventory logs. Other duties as assigned. Qualifications
High school diploma/GED required; Bachelor’s degree desirable. Experience preferred in a GXP manufacturing environment or similar. Highly detail-oriented and organized; able to work independently and as part of a team with a positive attitude. Physical requirements: ability to lift up to 50 lbs and to walk, stand, or sit for extended periods. Pay and Benefits
The annual pay range for this position in California is $55,000 – $65,000. Final salary varies based on experience, skillset, education, and business needs. This range may not reflect positions in other states. Benefits include medical, dental, and vision coverage effective day one of employment; 401(k) with company match; PTO and holidays; tuition reimbursement; wellness programs; and additional employee perks. About Catalent
Catalent is a global leader in drug development and manufacturing, supporting clients from discovery to market with a focus on quality and patient safety. Catalent is an Equal Opportunity Employer. Note: If you require accommodations in the application or hiring process due to a disability, please contact DisabilityAccommodations@catalent.com.
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