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

TzRZR2ZsbnYySHppVzZ3clFrREREM3BI
  • Polaris Pharmaceuticals Inc.
  • Vacaville, CA

Job Description

Role Title : Manufacturing Associate I/II (Downstream)

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

ZipRecruiter

Maintenance Electrician Job at ZipRecruiter

Job DescriptionJob DescriptionMaintenance Electrician - 2nd Shift | Now Hiring | Santa Fe Springs, CACompensation Includes:Starting rate of $36.51-40/hour - paid weeklyAvailable Shift:2nd Shift: 2:00pm - 10:30pmBenefits Include:Eligible for benefits first... 

Coach

Temporary Support Associate Job at Coach

Coach is seeking a Temporary Support Associate in Simpsonville, KY, to assist with merchandising, customer service, and inventory management. This role involves maintaining the store's visual presentation and supporting sales associates. Ideal candidates will have retail... 

BOEING

Embedded Software Engineers (Associate/Experienced/Senior) Job at BOEING

 ...Company is currently hiring for Embedded Software Engineers (Associate/Experienced/Senior)...  ...team environment helping to develop real-time software solutions, utilize simulations...  ...Basic Qualifications (Required Skills/ Experience): 2+ years of professional software development... 

PNC Financial Services Group

Teller Job at PNC Financial Services Group

 ...opportunity to contribute to the companys success. As a Full Time Teller within PNC's Retail organization, you will be based in Payson,...  ...available for their financial interactions. Identifies banking opportunities during the customer interaction and refers as appropriate... 

Bandwidth Inc.

AI/ML Engineer, Research & Development Job at Bandwidth Inc.

 ...shaped group, diving deep into emerging areas like Artificial Intelligence and Machine Learning. We're seeking a highly motivated AI/ML Engineer to join this dynamic team in our Raleigh, NC headquarters. You thrive in a collaborative, fast-paced environment where you...