Engineer, Quality Control (GAMP)

Company: Avid Bioservices
Location: Tustin
Posted on: May 9, 2022

Job Description:

Job DescriptionSUMMARYThe Quality Engineer is an individual contributor who performs a wide variety of activities to ensure compliance with applicable quality and regulatory requirements. Primary responsibilities include reviewing and approving change controls for validated systems such as critical utilities, manufacturing equipment, analytical instruments, and computerized systems. This role writes and revises SOPs and related manufacturing documents and may conduct investigations related to manufacturing processes.ESSENTIAL DUTIES AND RESPONSIBILITIES • Review changes for impact on product, the validated state of systems, and manufacturing processes to ensure GMP compliance.• Review and approve change requests pertaining to facility and manufacturing process through reviewing and approving validation documents, standard operation procedures (SOPs), and other pertinent documents.• Attend change control review meetings and monitor the overall state of the change control system pertaining to equipment and facility changes.• Provide guidance and collaborate with change request initiators, Subject Matter Experts (SMEs), and management to resolve change control related issues.• Interact with interdepartmental contacts on discrepancy assessment, resolution, and quality approval• Participate in discrepancy investigations to ensure discrepancies are thoroughly identified, defined and properly assessed• Review and approve controlled documents relating to processes, equipment, facilities and utilities in the manufacture of product• Identify, design, and implement process improvements• Provide technical assessment and approval for controlled document changes• Apply advanced theory, technical principles, expert judgment, and cross-functional expertise to independently address a broad range of complex problems• Identify, design, and implement process and system improvements• Notify Management of potential quality or regulatory issues that may affect product quality or regulatory complianceQUALIFICATIONS• A four year B.A. or B.S. degree in Life Sciences is required.• Require a minimum of 3 - 7 years of experience in the pharmaceutical or biopharmaceutical industry. • Must have sound knowledge of cGMPs or equivalent regulations.• The ability to interpret and relate Quality standards for implementation and review is required.• Must be able to make sound decisions about scheduling, allocation of resources and managing priorities.• Will need excellent professional communication skills both verbally and in writing.• Should have flexibility in problem solving, providing direction, and work hours to meet business objectives.COMPUTER SKILLSTo perform this job successfully, an individual should have knowledge of computers, word processing, spreadsheet, and internet software. Proficiency in technical writing and data analysis using Excel are essential. Ability to operate analytical equipment using MS Windows based software systems is required.RELOCATION AVAILABLEPlease note this position is based in Orange County, CA and is a full time onsite role. Competitive relocation assistance within the continental USA will be provided for well-qualified individuals.EQUAL OPPORTUNITY/AFFIRMATIVE ACTION EMPLOYERPeregrine Pharmaceuticals and Avid Bioservices do not discriminate against any employee or applicant for employment because of race, color, religion, sex, national origin, age, marital status, genetic information, disability or because he or she is a protected veteran.

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Keywords: Avid Bioservices, Tustin , Engineer, Quality Control (GAMP), Engineering , Tustin, California