Overview
Specialist, Quality Assurance Jobs in Los Angeles, California, USA at TalentBurst
Job Title:
Specialist, Quality Assurance
Location:
West Hills
Duration: 06 months
The incumbent is responsible for the continued implementation and operation of Quality Assurance processes. This role will oversee Asset Management, Batch Records, Change Management, Deviation and CAPA, GMP Cleanroom Support, Lot Disposition, Quality Control (QC) Data, Quality Risk Management (QRM), Raw Materials.
Key
Role and Responsibilities:
Implementation of GMP Quality Operations
Collaborate with key stakeholders and system owners on the continuous improvement of the Quality GMP processes at West Hills. Create and/or collaborate on corresponding SOPs.
Represent Quality Assurance on project specific teams, as needed.
Perform review and approval of executed batch records, and resolution of discrepancies with manufacturing personnel.
Perform review and approval of Change Management deliverables.
Perform review and approval of Deviation and CAPA record deliverables.
Provide quality support for manufacturing operations in the cleanroom facilities (e.g., changeover/line clearance support, APH receipt, product pack-out, event triage).
Perform review of final product lot file and lot disposition.
Participate in QRM activities (e.g., serve as Quality representative for risk assessments).
Perform review and disposition of incoming raw materials, and approval of raw material specifications.
Author and/or collaborate on the creation and revision of Standard Operating Procedures across the West Hills site.
Support other routine Quality operations as required, commensurate with experience and the West Hills site maturation.
Skills:
A minimum of 6 years in GMP biopharmaceutical operations with a minimum of 4+ years in a GMP Quality role.
Experience in clinical manufacturing.
Role
Description:
Experience with quality management systems (e.g. deviations, CAPAs, change management).
Knowledge, Skills and Abilities:
Fast learner, adaptable, with enterprise viewpoint and excellent cross-collaboration and inter-personal skills.
The desire and ability to work in a fast-paced, start-up environment.
Motivated and organized critical thinker with solid interpersonal and business communication skills.
Demonstrated ability to work effectively with a team to set goals, develop sound project plans, monitor progress, and report results.
Ability to work efficiently, prioritize workflow, meet deadlines and balance competing priorities.
Excellent analytical skills and scientific/technical expertise.
Physical Requirements:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. While performing their duties, the employee must be able to do the following:
Confirm visual information in the environment such as; batch record and SOP steps were completed properly, parameters on equipment and computer screens, status of materials and equipment, and perform visual inspection of materials and product. A vision test may be required. Use of corrective lenses is acceptable.
Stand and step over a gowning bench (12-24”) and aseptically don head-to-toe nonsterile and sterile gowns. Shift Work, Weekend Work, and Holiday Coverage:
Due to the nature of our autologous cell therapies and the need to deliver life-saving treatments to our patients as timely as possible, shift work, weekend work, and holiday work will be required.
Education:
BSc degree with 7 years’ experience in biology, biochemistry, chemical engineering, bioengineering, or related technological field.
MSc degree with 4 years’ experience in biology, biochemistry, chemical engineering, bioengineering, or related technological field.
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Title: Specialist, Quality Assurance
Company: TalentBurst
Location: Los Angeles, California, USA
Category: Quality Assurance – QA/QC, Healthcare
