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.
Job Posted by ApplicantPro
Keywords: Avid Bioservices, Tustin , Engineer, Quality Control (GAMP), Engineering , Tustin, California
Click
here to apply!
|