Title: Manufacturing Associate I - Downstream
Duration: 06 months
Location: Fremont, CA 94555
Shift: 2nd Shift: 2:00PM - 12:30AM (Sun-Wed)
 
Duties:

• Executes routine unit operations in Downstream manufacturing as assigned related to the manufacturing of bulk drug substance in a multi-product facility.
• Performs duties under limited supervision and according to standard operating and manufacturing procedures.

 
Processing:

• Executes independently with adequate training non-complex fundamental operations as parts cleaning, weigh and dispense, equipment prep, kits assembly, and staging.
• Performs internal support duties including stocking consumables/materials, updating controlled SOP binders appropriately discarding expired reagents, recognizing and reporting process and equipment anomalies.
• Executes with oversight of qualified staff fundamental tasks as CIP and SIP of BR's, tanks, manufacturing equipment as well as media or buffer prep and transfer into tanks and bags.
• Daily analytics and maintenance of analytical equipment.
• Cleaning and setup of equipment

 
Quality/Compliace

• 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 production areas according to predefined standards (5s).
• Keeps own training on track and trains other technicians and associates on operations.
• Contributes to Quality activities as investigations and area walk-throughs.
• Working in a highly regulated environment following all applicable client’s SOPs, OCPs and BGSs for cGMP, EHS and Compliance policies.
• Required to work according to given schedules in a 24/7 shift structure and flexibility to adapt working schedule upon prior given notice.
• Strong focus on execution of routine tasks with moderate technical complexity.
• Performs highly proceduralized tasks.
• Basic interactions with Manufacturing Cell Culture, Manufacturing Purification, Manufacturing Compliance, Engineering & Technology, Supply Chain, Quality Assurance, Quality Control
• Basic knowledge of fundamental manufacturing concepts is preferred.
• Does not require extensive technical knowledge of manufacturing operations.
• Executing repeatable, highly proceduralized operations.
• Complex operations performed under supervision.

 
Skills:

• Detail-oriented with the ability to concentrate on 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.
• Working in a highly regulated environment following all applicable client’s SOPs, OCPs and BGSs for cGMP, EHS and Compliance policies.
• Required to work according to given schedules in a 24/7 shift structure and flexibility to adapt working schedule upon prior given notice.

Physical Demands:

• Able to lift 25 lbs.
• Use of a ladder will be involved.

 
Education:

• High school degree, entry level position.
• Associates/Bachelor’s degree from an accredited institution or biotechnology vocational training preferred.
• Preferable one (1) or more years of experience in cGMP regulated industry

 

About Us: SPECTRAFORCE is one of the fastest-growing workforce solutions firms in the United States. As a diversity-owned business, we place human connection at the heart of everything we do, building strong relationships with both clients and candidates to fill roles successfully. Our teams in North and Central America and India serve more than 150 Fortune clients globally, leveraging custom AI technology to provide direct hire, executive search, nearshoring, offshoring, and project staffing solutions.
 
Benefits: SPECTRAFORCE offers ACA compliant health benefits as well as dental, vision, accident, critical illness, voluntary life, and hospital indemnity insurances to eligible employees. Additional benefits offered to eligible employees include commuter benefits, 401K plan with matching, and a referral bonus program. SPECTRAFORCE provides unpaid leave as well as paid sick leave when required by law.

Equal Opportunity Employer: SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at LOA@spectraforce.com if you require reasonable accommodation.
 
California Applicant Notice: SPECTRAFORCE is committed to complying with the California Privacy Rights Act (“CPRA”) effective January 1, 2023; and all data privacy laws in the jurisdictions in which it recruits and hires employees. A Notice to California Job Applicants Regarding the Collection of Personal Information can be located on our website. Applicants with disabilities may access this notice in an alternative format by contacting NAHR@spectraforce.com.
 
LA County, CA Applicant Notice: If you are selected for this position with SPECTRAFORCE, your offer is contingent upon the satisfactory completion of several requirements, including but not limited to, a criminal background check. We consider qualified applicants with arrest or conviction records for employment in accordance with all local ordinances and state laws, including the Los Angeles County Fair Chance Ordinance for Employers (FCO) and the California Fair Chance Act (FCA). The background check assessment will consider whether a criminal history could reasonably have a direct, adverse impact on the job-related safety, security, trust, regulatory compliance, or suitability for this role. Such findings may result in withdrawal of a conditional job offer. 


At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $23.00/hr.