Senior Associate Data Management

Fremont, CA 94555

Posted: 03/22/2019 Employment Type: Contract Industry: Clinical & Scientific Job Number: 15365

Bayside Solutions is seeking a Senior Associate Data Management to be part of our client’ s team in Fremont. This is an opportunity to work with the largest privately held pharmaceutical corporation in the world and ranks among the world' s 20 leading pharmaceutical corporations.

Our Client’ s culture is highly collaborative, offers an environment that encourages employees to expand their knowledge in order to make a profound impact on patients’ lives. This could explain why their company has been recognized as one of the “ Top Twenty Employers” in biotechnology and pharmaceuticals by Science Careers.

Our Company Bio:  Bayside Solutions was founded in 2001, Bayside was recognized as one of the fastest growing professional staffing companies in Northern California. The numbers tell the story: We have close to a 100% client retention rate, 700% growth in four plus years and over 95% repeat business. Our dedication to building partnership relationships with both our clients and our recruits is the key to our phenomenal success.

You can find additional information on our company website at www.baysidesolutions.com.

Senior Associate Data Management:

Job Benefits:
  • An opportunity to join a patient-focused organization that is driven to develop, manufacture and commercialize medicines to treat life threatening conditions.
  • Work for a company that is local to the bay area and recognized as a leader of innovation.
  • Competitive compensation commensurate with experience.
  • This position is eligible for medical, vision, dental benefits, paid sick time, and 401K.

Summary of Responsibilities:
  • Executes and coordinates test record issuance and reconciliation for QC data management.
  • Compiling stability test result binders per product specific protocol.
  • Monitoring stability program including updating data spreadsheet and stability reports.
  • Archiving Test record binders. Compiling QC data package for lot release and method specific in QC labs.
  • Created Cofa and In-process Testing reports related to the manufacturing of bulk drug substance and drug product in a multi-product facility. 
  • Created Cofa and In-process Testing reports.
  • Performs duties under limited supervision and according to standard operating procedures.
  • Documents work according to cGMP and cGDP.
  • Performs duties under limited supervision and according to standard operating procedures.
  • 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 work areas according to predefined standards (5s).
  • Maintains own training within compliance and trains other technicians and associates on operations upon completion of trainer qualification. 

Summary of Qualifications:
  • Associates degree required, Bachelors degree preferred.
  • 2 or more years of experience in cGMP regulated industry. 
  • Ability to concentrate on detail oriented work in a complex technical setup with a Quality and Right the first time mindset.
  • Strong written and verbal communication skills.
  • Ability to work with computer-based systems.
  • Ability to read and understand SOPs and work instructions and document work in a written format applying cGMP standards.
  • Ability to work as part of a high performing team and collaborate effectively with staff.

Erik Cordova

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