211550 - Scientist l
Industry
SCI
Region
CA-Bay Area
City
Fremont
State
CA
Rate
Up to $33.00 DOE
Duration
12 Months
Description
Chipton-Ross is seeking a Scientist l for a contract opportunity in Fremont, CA.

SUMMARY:
You will be responsible for manufacturing products for the Bulk Formulations TDM team and complete associated cGMP documentation. You will work with chemicals and biologicals to manufacture reagents, calibrators, and controls for IVD immunoassay use and participate in process improvement projects.

RESPONSIBILITIES:
Manufacture products including reagents, calibrators, buffers, controls, etc. and complete batch records while maintaining cGMPs and GDP standards
Perform in-process testing using clinical analyzers and analyze raw data for in-process adjustments and product release
Review other manufacturing operators/scientist's batch records
Maintain and analyze lot histories for trends and discrepancies
Perform laboratory activities including weighing, transferring, and mixing required chemicals and performing product filtration
Participate in process improvement projects to improve operational efficiencies and support business needs
Modify SOPs, work instructions and reports with mentorship
Initiate and support investigations for quality documentation including NCARS, CAPAs, and Variances
Maintain and troubleshoot testing and formulations equipment as appropriate
Keep department supervisor and/or manager updated on all issues
Perform other job duties as the need arises

REQUIRED EXPERIENCE:
1+ years of related experience and/or training preferred
Laboratory skills including pipetting, safety, and hazardous chemical handling and knowledge of safety precautions
Experience in working with potentially hazardous chemicals and human source materials preferred
Familiarity with Quality System Regulations and ISO 13485 regulations is a plus
IVD immunoassay manufacturing experience preferred
Ability to perform tasks in compliance with GMP, GDP, QSRs, ISO and IVD regulations
Self-sufficient, self-motivated, and focused

PHYSICAL REQUIREMENTS:
Ability to routinely lift 25 pounds

HARD REQUIREMENTS:
Must be organized, detail-oriented, and can prioritize own and other's work to meet business efficiency metrics

EDUCATION:
Accredited BS/BA in a scientific field in Chemistry, Biochemistry, or related technical discipline; equivalent combination of education and years of related experience may be substituted.

WORK HOURS:
Full-Time; Days

Employment will be contingent on clearing a drug screen and background check. Both must clear prior to start date.

Contact
Zachary Fasano
zfasano@chiptonross.com
CHIPTON-ROSS, INC.
420 Culver Boulevard
Playa Del Rey, CA 90293

Phone: (310) 414-7800 x252 or (800) 927-9318 x252

Candidates responding to this posting must currently possess the eligibility to work in the United States. No third parties please.

Employment will be contingent on candidate clearing pre-employment drug screen and background check.

Chipton-Ross provides equal employment opportunities to all employees and applicants for employment without regard to race, color, creed, religion, national origin, sex (including pregnancy), age, disability, sexual orientation, gender identity and/or expression, protected veteran status, genetic information, or any other characteristic protected by Federal, State or local law. This policy governs all areas of employment at Chipton-Ross, including recruiting, hiring, training, assignment, promotions, compensation, benefits, discipline, and terminations.