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Quality Assurance Associate II - Manufacturing - San Diego California
Company: Disability Solutions Location: San Diego, California
Posted On: 05/03/2024
Quality Assurance Associate II - Manufacturing Catalent Pharma Solutions in San Diego is currently hiring a Manufacturing Quality Assurance (MQA) Associate II who is responsible for a wide variety of activities pertaining to supporting, maintaining, and assuring compliance with quality systems requirements and applicable regulatory requirements; to advance the development and manufacture of drug candidates. This will include documentation review and approval, dispositioning of product or its intermediates & supporting manufacturing operations.This position is 1st shift Monday-Friday from 8am-5pm.Catalent is a global, high-growth, public company and a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide. Your talents, ideas, and passion are essential to our mission: to help people live better, healthier lives. -Catalent Pharma Solutions in San Diego is a premier pharmaceutical chemistry development and manufacturing organization supporting the pharmaceutical and biotechnology industries. We focus on bringing client drug compounds from discovery to the clinic with services that include analytical development, pre-formulation testing, formulation development, GMP manufacturing and stability storage and testing as well as Clinical Supply Services. -At Catalent San Diego, we recruit and develop exceptional individuals with a passion for science and determination to excel. We offer a technically challenging and stimulating environment and the opportunity to learn from the best.Catalent is committed to a Patient First culture through excellence in quality and -compliance, and to the safety of every patient, consumer, and Catalent employee.The Role: - 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 client, effectively communicates with clients in regards of Executed Batch Records and review status;
- Tracks status of EBR's and maintains established deadlines for completion of review and corrections;
- Reviews and approves GMP product labels;
- Support GMP manufacturing activities including release of GMP materials, shipment verification and performance of line clearances in a Class 100,000 environment, maintenance of clinical trial material inventory logs;
- Duties include but not limited to hosting client and regulatory audits, Non-conformance and Environmental Monitoring review, Master Batch Record review and approval, Deviation & Investigation review and approvals, Occasional SOP revision and review, and Occasional training of other QA personnel;
- Other duties as assignedThe Candidate:
- Bachelor's degree required, Chemistry or Biochemistry preferred;
- Candidate will have 2+ years of work experience, preferable in a GXP manufacturing environment or similar;
- Candidate must also be highly detail-oriented and organized, able to work both independently and as a team player with a positive attitude;
- All other duties as assignedPay:
- The annual pay range for this position in California is $55,000 - $65,000 annually. The final salary offered to a successful candidate may vary, and will be dependent on several factors that may include but are not limited to: the type and length of experience within the job, type and length of experience within the industry, skillset, education, business needs, etc. - Catalent is a multi-state employer, and this salary range may not reflect positions that work in other states.Why you should join Catalent:
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