Specialist, Quality Assurance (Early Phase)

Avid Bioservices•Costa Mesa, CA

111d•$33 - $41•Onsite

About The Position

The Quality Assurance Specialist (Early Phase) is an individual contributor who resolves a variety of issues in accordance with cGMP regulations and company standards. The role maintains inspection readiness and supports departmental and company goals by collaborating with management, serving as a Quality representative on cross-functional and multi-site teams, identifying potential procedure, process, and system gaps, and recommending solutions. The Specialist applies basic theory and technical principles to moderately complex problems, troubleshoots Quality issues, serves as a technical subject matter expert, and provides Quality oversight and customer support. Core duties include reviewing manufacturing batch production records, associated forms and paperwork, batch history records, and testing documentation from Microbiology and Chemistry. The Specialist assists with API batch and lot release and discrepancy investigations; reviews and approves controlled documents related to manufacturing processes, equipment, facilities, and utilities; writes and assists with excursion reports; and interacts with departments on discrepancy assessment, resolution, and quality approval. The role also supports initiatives, helps ensure review activities follow governing SOPs, generates departmental performance metrics, and performs assigned work in accordance with company policies and procedures. This is a full-time, onsite position, generally working Monday through Friday. Overtime and/or weekend work may be required when necessary. The physical work includes sitting, standing, walking, and occasional lifting of objects up to 25 pounds. The work environment may occasionally involve exposure to electrical shocks, toxic chemicals, vibrations, or loud noise. Reasonable accommodations are available.

Requirements

B.A. or B.S. degree; preferably in a life science discipline.
At least 2 years of experience in the biopharmaceutical industry.
Knowledge of cGMPs or equivalent regulations.
Ability to interpret quality standards for implementation.
Ability to independently evaluate situations and propose potential solutions.
Strong written and verbal communication skills.
Multitasking skills and attention to detail.
Ability to build relationships with team members, clients, vendors, and suppliers.
Ability to work overtime and/or weekends when necessary.
Ability to perform work involving sitting, standing, walking, and occasional lifting of objects up to 25 pounds.
Visual acuity including close, distance, and color vision.

Responsibilities

Maintain a state of inspection readiness.
Provide input to personal performance goals and departmental objectives, and collaborate with management to establish and meet targets and timelines.
Serve as a Quality representative on cross-functional, multi-site, and multidisciplinary project teams.
Identify and recommend solutions to potential procedure, process, and system gaps.
Provide assistance to customers in support of departmental functions and provide Quality oversight to internal and external customers.
Participate in the design and implementation of departmental and cross-functional initiatives.
Apply basic theory and technical principles to address moderately complex problems.
Troubleshoot Quality issues and initiate resolution through effective interdepartmental and cross-functional partnerships.
Serve as a technical subject matter expert in support of department functions.
Sign documents for activities as authorized by company policies, procedures, and job descriptions.
Review Manufacturing Batch Production Records and associated manufacturing forms and paperwork.
Assist in the release of API batches and lots.
Assist with discrepancy investigations and compile and perform QA review of batch history records.
Review testing documentation from Microbiology and Chemistry groups.
Review and approve controlled documents relating to manufacturing processes, equipment, facilities, and utilities.
Write and assist with excursion reports.
Interact with interdepartmental contacts on discrepancy assessment, resolution, and quality approval.
Collaborate with departments to ensure review activities are executed efficiently in accordance with governing SOPs.
Generate departmental performance metrics for management review.
Perform assigned tasks and work toward company goals and department objectives in accordance with company policies and procedures.