Advantage Technical is seeking a talented and passionate Scientist for our client in Fremont, CA.
Job Title: Scientist II, Formulations
Reports To: Operations Value Stream Sr Manager
Day/Shift (if applicable): Day
Manufactures products for the Controls Value Stream and completes associated cGMP documentation. Works with chemicals and biologicals to manufacture reagents, calibrators, and controls for IVD use. Participates in process improvement projects.
Manufactures complex products following cGMP and completes all necessary documentation in accordance with quality system Perform in-process testing using clinical analyzers. Review and analyze data.
Review other manufacturing operators/scientists batch records.
Maintain and analyzes lot histories for trends and discrepancies.
Weigh, transfer, and mix required chemicals
Perform product filtrations
Participate in process improvement projects to improve efficiencies and support business needs.
Reviews and modifies SOPs, work instructions and reports.
Initiate, evaluate, and support investigations for non-conformances, CAPAs, and Variances
Perform in-process assays using clinical analyzers. Review and analyze data. Maintain and troubleshoot equipment as appropriate.
Keep department supervisor and/or manager updated on all issues
Acts independently to determine methods and procedures on new assignments.
Perform other job duties as required.
Bachelors degree in Biology, Biochemistry or scientific related discipline
2 -4 years related experience and/or training preferred. Equivalent combination of education and years of related experience may be substituted.
IVD manufacturing experience is a plus
Strong laboratory skills and knowledge of safety precautions
Experience in working with potentially infectious materials, hazardous chemicals, and human source materials
Familiarity with Quality System Regulations and ISO 13485 regulations
Must be able to lift 25 lbs routinely
Non-Negotiable Hiring Criteria:
Must perform tasks in compliance with GMP, GDP, QSRs, ISO and IVD regulations
Strong laboratory skills including pipetting, safety, and hazardous chemical handling
Must be organized and detail oriented to be able to prioritize own and others work and meet business productivity metrics
Self-sufficient, self-motivated, and focused
About Advantage Resourcing
Advantage Resourcing is committed to providing equal employment opportunity for all persons regardless of race, color, religion (including religious dress and grooming practices), sex, sexual orientation, gender, gender identity, gender expression, age, marital status, national origin, ancestry, citizenship status, pregnancy, medical condition, genetic information, mental and physical disability, political affiliation, union membership, status as a parent, military or veteran status or other non-merit based factors. We will provide reasonable accommodations throughout the application, interviewing and employment process. If you require a reasonable accommodation, contact us. Advantage Resourcing is an E-Verify employer. This policy is applicable to all phases of the employment relationship, including hiring, transfers, promotions, training, terminations, working conditions, compensation, benefits, and other terms and conditions of employment.
All employees are directed to familiarize themselves with this policy and to act in accordance with it. All decisions with respect to employment matters and other phases of employer-temporary employee relationships will be in keeping with this policy and in accordance with all applicable laws and regulations.
PandoLogic. Keywords: Biochemist, Location: Fremont, CA - 94537