QA Documentation Specialist – Contract – San Dimas, CA - $20.00-$23.00/hr
The end client is unable to sponsor or transfer visas for this position; all parties authorized to work in the US without sponsorship are encouraged to apply.
A Biotechnology Company is seeking a QA Documentation Specialist in San Dimas, CA.
• Processing documents following defined processes/procedures, scanning, filing, indexing of GxP related documents and records and coordination of off-site records
• Analyze Change Requests for completeness. Communicates with customers to ensure changes are concise and complete
• Ensures the correct and timely implementation of Change Requests (CR), Document Change Orders (DCOs) and Documents
• Supports the distribution and maintenance of GxP documentation
• Provides clerical and administrative support related to documentation and systems
• Maintains documentation manuals to ensure accuracy and current information
• Scans, verifies and archives documentation and records
• Ensure the correct and timely input of database entries, verifies own work
• May participate in training users for electronic systems (as applicable)
• Understand and use document templates
• Supports the maintenance of monthly document control metrics
• Performs general word processing tasks and support. Checks format and conformance to document templates. Verifies own work.
• Provides support for internal and regulatory audits/inspections as required
• Provides additional support and assistance on tasks and projects as directed by management
• Participates as required in training on issues affecting own are of work. Notifies manager of compliance questions and issues Knowledge and Skills
• Demonstrates working knowledge of Document Control fundamentals, Quality Systems and GMP requirements
• Demonstrates basic understanding of the current pharmaceutical industry and applicable regulations including 21 CFR, GxP, ICH, etc
• Demonstrates basic knowledge of Electronic Document Management Systems (EDMS)
• Keeps abreast of the basic requirements for compliance in own work area
• Demonstrates detail orientation and problem-solving skills
• Demonstrates proficiency in Microsoft Office applications and Oracle environment
• Demonstrates ability to work effectively in a team environment
• Demonstrates strong verbal, written and interpersonal communication skills
Skills & Requirements
• 5+ years of relevant experience in the pharmaceutical industry and a high school diploma
• 3+ years of experience and AA degree
You will be working with a professional recruiter who has intimate knowledge of the industry and market trends. Your Hays recruiter will lead you through a thorough screening process in order to understand your skills, experience, needs, and drivers. You will also get support on resume writing, interview tips, and career planning, so when there’s a position you really want, you’re fully prepared to get it.
Additionally, this position is a contract role where Hays offers you the opportunity to enroll in full medical, dental or vision benefits.
• Life Insurance ($20,000 benefit)
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Hays is an Equal Opportunity Employer including disability/veteran.
In accordance with applicable federal and state law protecting qualified individuals with known disabilities, Hays U.S. Corporation will attempt to reasonably accommodate those individuals unless doing so would create an undue hardship on the company. Any qualified applicant or consultant with a disability who requires an accommodation in order to perform the essential functions of the job should call or text 813.336.5570.
Drug testing may be required; please contact a recruiter for more information. #1142624