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QC Associate II

Fremont, CA 94555

Posted: 08/23/2024 Employment Type: Contract Job Category: Quality and Compliance Job Number: 614003 Is job remote?: No Country: United States

Job Description

Duties:
  • Execute and coordinate routine and non-routine testing in Quality Control (QC) for bulk drug substances and drug products within a multi-product facility.
  • Perform fundamental operations independently, such as biochemistry, drug product device testing, UV-Vis absorbance, gel electrophoresis, pH, and osmolality, following adequate training.
  • Provide internal support including stocking consumables/materials, updating controlled SOP binders, discarding expired reagents, and recognizing/reporting process and equipment anomalies.
  • Deliver high-quality analytical results within specified timelines and with accuracy ("right the first time").
  • Document work in compliance with current Good Manufacturing Practices (cGMP) and current Good Documentation Practices (cGDP).
  • Adhere to established regulations and site-specific cGMP standards.
  • Report abnormalities and deviations in a timely and accurate manner.
  • Follow safety standards, identify unsafe situations or habits, and escalate as necessary.
  • Maintain work production areas according to predefined standards (5S).
  • Maintain compliance with training requirements and train other technicians and associates on operations upon completion of trainer qualification.
  • Represent QC operations on cross-functional root cause analysis teams for deviations, Corrective and Preventive Actions (CAPAs), and risk assessments.
Skills:
  • 3-5 years of industry experience.
  • GMP experience is highly preferred.
  • Strong interpersonal and communication skills (both written and oral).
  • Demonstrated customer focus and ability to interact with various departments and levels.
  • Ability to work independently and as part of a team to meet departmental and facility goals.
  • Capable of working across functions to achieve common objectives.
  • Strong attention to detail and focus on the execution of tasks.
Education:
  • Bachelor’s degree in Biology or Life Sciences required.







Pay Rate Range: $20-34/hr. Salary will be commensurate with experience 

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma and The Planet Group of Companies are equal opportunity employers. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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About Fremont, CA

Join us in Fremont, California, where exciting job opportunities await! Nestled in the heart of the San Francisco Bay Area, Fremont offers a vibrant mix of culture, innovation, and natural beauty. Home to landmarks like the Niles Essanay Silent Film Museum and the Ardenwood Historic Farm, this diverse city boasts a rich arts scene, delicious cuisine, and proximity to major tech companies and Silicon Valley. With easy access to outdoor recreation at the Don Edwards National Wildlife Refuge and the Mission Peak Regional Preserve, Fremont is the perfect place to grow your career and enjoy a high quality of life. Explore our job listings today and discover the charm of Fremont!

Although this hasn't been an issue at Planet Pharma, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.