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Date Added: Fri 04/06/2021

GMP Sr. Specialist, Quality Assurance (On Production Floor)

Tustin, CA, US
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Company: AVID BIOSERVICES

Job Type: Permanent, FullTime

Job Description

Avid Bioservices Inc., located in Tustin CA, is a dedicated contract development and manufacturing organization ("CDMO") focused on development and CGMP manufacturing of biopharmaceuticals products derived from mammalian cell culture. Avid provides a comprehensive range of process development, high quality CGMP clinical and commercial manufacturing services for the biotechnology and biopharmaceutical industries. With over 28 years of experience producing monoclonal antibodies, enzymes, and recombinant proteins in batch, fed-batch, and perfusion modes, Avid's services include CGMP clinical and commercial product manufacturing, purification, release and stability testing as well as regulatory strategy, submission and support. Avid also provides a variety of process development activities, including cell culture and feed optimization, analytical methods development, and product characterization.

We are dedicated to the improvement of global patient outcomes by delivering world-class services. Our expertise enables us to partner with our customers to advance their products from clinical development to commercial launch. Are you trained in Good Manufacturing Practices ("GMP") and looking for a role that allows you to be on the production floor as a Quality Assurance representative? If so, apply today!

In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire.

Covid-19 Hiring Update: We are continuing to interview and hire during this time. Avid Bioservices' is committed to caring for the safety and well-being of applicants and employees; all interviews will be completed over the phone or virtually.

Summary: The Quality Assurance Specialist provides compliance oversight of Manufacturing production activities. Supports the review of batch records and quality investigations. Performs assigned tasks and works to achieve company goals and department objectives.

Essential Duties and Responsibilities:

  • Review of batch production records and quality investigations
  • Review of Manufacturing forms and paperwork in association with Batch Production Records
  • Advise production on proper documentation requirements as needed
  • Initiate deviations, assist in area investigations, and review of discrepancy reports
  • Maintain a state of inspection readiness
  • Maintain company quality and safety standards
  • Collaborate with Management to establish and meet targets and timelines
  • Independently manage competing priorities with limited instruction
  • Serve as a Quality representative on cross-functional and multi-site teams
  • Identify and recommend solutions to potential procedure, process and system gaps
  • Troubleshoot and initiate the resolution of Quality issues by fostering effective interdepartmental and cross-functional partnerships
  • Represent Quality Assurance on multi-disciplinary project teams
  • Collaborate with departments to ensure that all review activities are executed efficiently per governing SOPs
  • Perform tasks as requested by Management to support Quality oversight activities

Qualifications:

  • B.A. or B.S. degree in the Life Sciences field
  • Minimum of 4 years of experience in the biopharmaceutical industry
  • Must be able to gown for a class 10,000 cleanroom environment
  • Proficient knowledge of cGMP
  • Ability to interpret Quality standards for implementation

Skills:

  • Ability to make sound compliance-related decisions with minimal supervision
  • Must have strong attention to detail
  • Proficient knowledge of cGMP
  • Strong communication (written and verbal) and organizational skills
  • Strong problem solving and teamwork skills

Work Schedule and Hours:

Days and hours of work are initially Monday through Friday, 8/9:00 a.m. to 5/6:00 p.m. and after training, days and hours of work are either Sunday through Wednesday or Wednesday through Saturday, 7:00 a.m. to 6:00 p.m. unless otherwise stated by Supervisor. The employee must also, if instructed, have the ability to work overtime and/or weekends when necessary.


EQUAL OPPORTUNITY/AFFIRMATIVE ACTION EMPLOYER

Avid Bioservices, Inc. does 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 the employee or applicant is a protected veteran.



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