Highlights
Overview: Provide expertise on routine and non-routine testing performed in QC laboratories of bulk drug substance and drug product in a multi-product facility. Assist and/or lead cross functional project team(s) responsible for complex QC related compliance deliverables throughout the entire Quality System (deviations, investigations, OOS and CAPAs and change controls).
Numbers & Facts
| Location | Fremont, CA |
| Industry | Staffing/Employment Agencies |
| Company Size | 500 to 999 employees |
| Website | https://www.thefountaingroup.com/ |
Description
Pay: $33.19/Hour
Duration: 6+ months
1st Shift: Mon-Fri, 9AM-5PM
Overview:
Skills:
Education:
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Duration: 6+ months
1st Shift: Mon-Fri, 9AM-5PM
Overview:
- Provide expertise on routine and non-routine testing performed in QC laboratories of bulk drug substance and drug product in a multi-product facility.
- Responsible for technical review, interpretation, trending, quality review and investigation of atypical results.
- Assist with quality risk assessments, onboarding, qualification and implementation of non-routine, new equipment validation activities.
- Assist with implementing Client improvements and new ways of thinking toward lab processes and compliance activities.
- Assist and/or lead cross functional project team(s) responsible for complex QC related compliance deliverables throughout the entire Quality System (deviations, investigations, OOS and CAPAs and change controls).
- Provide support during audits and inspections.
- Work independently with adequate training and background of fundamental operations such as biochemistry, drug product device testing, UV-vis absorbance, gel electrophoresis, Osmolalilty, Microbiology and more.
- Review of analytical results within timeline right the first time.
- Documents work according to cGMP and cGDP.
- Adheres to established regulations and follows cGMP established by site.
- Reports abnormalities and deviations in a timely and accurate manner.
- Adheres to safety standards and identifies unsafe situations / habits and escalates appropriately.
- Maintains own training within compliance and assist other technicians and associates on operations upon completion of trainer qualification.
- Represents QC operations on cross-functional root cause analysis teams for deviations, CAPAs and risk assessments
Skills:
- 3-5 years of industry experience
- GMP experience is highly preferred
- System familiarity that would be helpful: LIMS, Veeva & GoTrack
Education:
- Bachelors' degree in Biology or Life Sciences required.
By applying for this job, you agree to receive calls, AI-generated calls, text messages, or emails from and its affiliates, and contracted partners. Frequency varies for text messages. Message and data rates may apply. Carriers are not liable for delayed or undelivered messages. You can reply STOP to cancel and HELP for help. You can access our privacy policy at Privacy Policy
About Company
The Fountain Group provides Contingent Labor, Statement-of-Work, and Contingent-to-Permanent resources to clients with an internal/external Contingent Labor Managed Service Program or Clients without a program. The Fountain Group is committed to the belief that we all share in the responsibility to conduct our businesses in a socially and environmentally responsible manner. We base this on the premise that a company is much more than the products it offers. The effect a company has on the environment, the people and the communities it serves reflects the company’s dedication to being not only a good business, but to being a good corporate citizen. The Fountain Group believes the key to servicing a client is to identify the client demand precisely. Therefore, The Fountain Group focused its efforts on building and developing a process, which can identify an exact match for our client’s needs. Our process utilizes modern technology combined with 30+ years of Talent Acquisition experience to deliver Precision resources. Financial strength is prominent among The Fountain Group’s corporate values. The future of our business will be built on the innovation, compassion, outstanding services and technology, but a solid financial foundation is required to carry us forward to meet our business goal and support our long term vision.