Manufacturing Associate I/II Job at Polaris Pharmaceuticals Inc., Vacaville, CA

clZmSnc1emV4cVVsVkZPSnJGWWdmZU5yVVE9PQ==
  • Polaris Pharmaceuticals Inc.
  • Vacaville, CA

Job Description

Role Title : Manufacturing Associate I/II

Location : Vacaville

Department : Manufacturing

Supervisor : MFG Manager

FLSA : Exempt

Salary Range : $68,640-$70,000

CORE VALUES

Respect ● Passion ● Teamwork ● Integrity ● Honesty ● Commitment ● Collaboration

ROLE SUMMARY

The MFG Associate I is responsible for the manufacturing of Polaris’ drug substance and/or drug product portfolio. This includes support and collaboration with manufacturing customers and partners, including Quality, MSAT, Facilities, and management, that results in safe, high quality, and continuously improving production, while maintaining full compliance with current Good Manufacturing Practices, and Polaris’ corporate principles, quality policies, and standards. This position supports fermentation, purification (CLF), and aseptic fill suite (AFS) areas of manufacturing.

ROLE RESPONSIBILITIES

  • Daily GMP Manufacturing operation activities in the cleanroom and AFS
  • Daily Manufacturing support, cleaning, autoclave and parts wash
  • Work closely with Manufacturing leadership team, MSAT, Quality, and Scheduling to meet short and medium term objectives
  • Responsible for escalations as needed
  • Drive a culture of continuous improvement
  • Develop area technicians in both expertise and production knowledge
  • Comply with cGMP and GDP regulations
  • Order and dispense raw materials
  • Perform inventory cycle counts and site fit-for-use inspections
  • Perform revision and creation of SOP’s, batch records, or associated protocols under a change control program
  • Perform deviation initiation, investigation, resolution, and CAPA
  • Maintain Polaris’ right-to-operate: Ensure cGMP production of products in compliance with all applicable Health Authority requirements and Polaris’ Quality Management System Maintain inspection readiness, and serve as an area SME during inspection tours
  • Ensure systems and processes are properly maintained to ensure staff’s safety, product quality, and continuity of supply
  • Ensure that staff are appropriately trained and qualified for the activities they perform prior to execution
  • Ensure on-site presence for their staff and themselves
  • Work overtime (including outside of normal business hours) as needed per business requirements

JOB REQUIREMENTS

  • Bachelor’s degree, preferably in Life Sciences or engineering with 2-3 years of relevant work experience, or associates degree and 4+ years of relevant work experience, or high school diploma and 5+ years of relevant work experience
  • Knowledge of large molecule biopharmaceutical manufacturing processes and equipment
  • Ability to work on-site full-time as required
  • Ability to lift and carry up to 40 pounds
  • Work overtime as required, including outside of normal business hours
  • Ability to stand for a prolonged period operating manufacturing equipment, including in an ISO5 cleanroom

Job Tags

Full time, Temporary work, Work experience placement,

Similar Jobs

German Gallagher & Murtagh, P.C.

Associate Attorney Job at German Gallagher & Murtagh, P.C.

 ...The Philadelphia Office of German, Gallagher & Murtagh seeks a senior attorney with 5-8 years of experience defending civil litigation matters to support its growing casualty litigation practice. The associate will contribute to the firms litigation team and be responsible... 

Roquette

Quality Assurance Coordinator Job at Roquette

 ...Quality Assurance Coordinator Roquette is a family-owned global leader in plant-based ingredients and a leading provider of pharmaceutical excipients. Want to help us make a difference? Using plant-based resources, we collaborate with our customers and partners to... 

Trinity Health

Environmental Assistant Housekeeping Part Time AM Shift Job at Trinity Health

**Employment Type:**Part time**Shift:****Description:**Reporting to the Supervisor Environmental Services*, Environmental Services, this position is responsible for maintaining cleanliness, aiding in the prevention of cross contamination, controlling bacteria and odor... 

Acro Service Corp

Senior Buyer Job at Acro Service Corp

Job Title- Sr Buyer Location- Phoenix AZ USA 85027 Pay rate: $40/hour on W2 (US Citizen) Shift: 7:30am - 4:00pm Hybrid, 3 in office, 2 at home 1. Must have experience in negotiating contracts and managing supplier relationships. 2. SAP Description...

Idaho Kids Dentistry and Orthodontics

Dental Hygienist Job at Idaho Kids Dentistry and Orthodontics

Overview: Idaho Kids Dentistry and Orthodontics is seeking an outstanding individual to join our team as a Dental Hygienist in our Meridian office! Why choose Idaho Kids Dentistry and Orthodontics? Compassionate Pediatric Care: We specialize in caring for our littlest...