Medical Affairs Manager / Vaccine Trials (REMOTE-WORK)
Pioneer Data Systems
Thousand Oaks, CA
Thousand Oaks, CA
11 days ago
Our client, a world-leading Pharmaceutical Company in Thousand Oaks, CA is currently looking for a Quality Associate / Pharma Manufacturing to join their expanding team.
- Job Title: Quality Associate / Pharma Manufacturing
- Duration: 18 months contract, extendable up to 36 months
- Location: Thousand Oaks, CA
- The client has the right-to-hire you as a permanent employee at any time during or after the end of the contract.
- You may participate in the company group medical insurance plan
- Client requires all staff, staff augmentation external workers, and certain other external workers, in the United States and Puerto Rico to be vaccinated from COVID 19 as a condition of assignment.
- In accordance with applicable law, Client will provide reasonable accommodations to staff augmentation external workers who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship its operations, or its staff.”
- Biotech/ Pharma experience required
- The Senior Associate QA role supports Quality Assurance program, providing daily oversight of Drug Substance manufacturing facilities at Thousand Oaks.
- Under general supervision, the role provides support and compliance oversight to MFG and F&E staff in the execution of their processes, procedures, and use of quality systems.
- Duties include purposeful presence on the manufacturing floor, batch record review, SOP and MP revision approval, work order approval, and quality approval of deviations and CAPAs.
- Responsibilities will include evaluation of compliance issues, providing recommendations, and assuring progress of quality records to completion.
- The incumbent will also represent functional area quality for the Bulk Quality Assurance department in the execution of projects necessary to achieve departmental operational excellence goals and will work in a team matrix environment to ensure workplace safety.
- This staff member will be assigned to provide quality support during either day or night shift schedule periods, as operation support is 24/7.
- Bachelors degree with 1 YOE
- Masters degree
Top 3 Must Have Skill Sets:
- Experience in biotech or pharmaceutical industry supporting manufacturing areas as plant quality assurance, manufacturing, quality control, or related staff.
- Technical writing experience (i.e. deviation records, CAPA records, controlled documents)
- Excellent verbal and written cross functional communication skill
Day to Day Responsibilities:
- Purposeful presence on the manufacturing floor (80% of working time spent on MFG floor in controlled, classified cell culture and protein purification areas).
- Batch record review
- SOP and MP revision approval
- work order approval
- quality approval of deviations and CAPAs
- Safety auditing and observational work
- GEMBA walks
Employee Value Proposition:
- The person in this role will have to make decisions related to product quality and other critical areas.
- No biotech/pharma manufacturing, quality assurance, or quality control experience
- Unable to work shifts including morning, evening, or potentially nights
- Inability to effectively communicate across broad and diverse teams
About the Company
Pioneer Data Systems
Delivering professional consulting services since 1995. Our original area of focus was providing professional services for Oracle databases. As a market leader, we were recognized as a "New Jersey Technology Fast 50" company by Deloitte & Touche. Pioneer is a certified Minority Business Enterprise (MBE) and a recipient of Inc500 award for America's fastest growing private businesses. Over the years we have leveraged our expertise in the IT space and have diversified across market sectors, now catering to a wide range of practice areas, including Pharmaceutical / Clinical Research, Scientific, Engineering, Accounting and Finance. Many of our clients include Fortune 500 companies that have been trusting us to deliver the highest quality talent for well over a decade. Our strategic offshore location in Pune, India, allows us to take advantage of world time-tables, to offer the highest quality services around the clock. For further information on how our innovative delivery model can enhance your bottom-line, check out section Reduced Cost Per Hire. Our clients can rest assured our dedicated recruiting teams around the globe are committed 24 hours a day to driving forward our mission of acquiring the very best available talent for their staffing needs.
50 to 99 employees