Quality Assurance Specialist-Operations

The PolyPeptide Group - One of the world’s largest companies specializing in the manufacture of peptides and related compounds for research and pharmaceutical applications. More information is available at our website, www.polypeptide.com

QA Specialist-Operations

Independently assess various tasks associated with the disposition of the batch as assigned.

  • Deviations
  • CAPA
  • Batch record review
  • Annual product review
  • QC data and OOS review
  • Engineering Change Controls
  • Document Change Controls
  • C of A generation for clinical and commercial product release
  • Updating of SOPs
  • Material Review Reports
  • Interaction with contract testing labs.

Maintain a regular presence on the operation floor working with OPS team leads to review batch records on the floor and assess the state of daily events. Work with Operations to resolve minor events quickly. Report major/critical observations back to QA manager for assessment.

Support Engineering, Maintenance, and Production technical needs by reviewing PMs, Calibration documents, function tests, work orders, and other documentation as needed.

Release API batches after QA Manager review.

Review and release raw materials based on internal QC test results.

Back up activities of Quality Systems which includes supporting supplier audits, change control, CAPA, complaint handling, document control systems, and cGMP training of employees.

Ensure Quality System, cGMP and ICH guidelines are followed on site.

v Participate in annual analysis of upgrades to Quality System in terms of both Operations efficiency, as well as new FDA or ICH regulatory changes.

Partner with Regulatory Affairs, Project Management, Manufacturing, Development, Marketing as well as Corporate Quality on customer projects, regulatory submissions, and harmonization of PPL Group’s Global Quality standards across PPL Group sites.

Performs any and all additional duties as required for this position.

Education: Minimum Bachelors, life science (preferred)
Experience: 3-5 year relevant experience

Salary: DOE

Job Type: Full-time

Pay: $63,231.00 - $142,886.00 per year

Benefits:

  • 401(k)
  • 401(k) matching
  • Dental insurance
  • Employee assistance program
  • Employee discount
  • Flexible spending account
  • Health insurance
  • Life insurance
  • Paid time off
  • Parental leave
  • Referral program
  • Relocation assistance
  • Retirement plan
  • Tuition reimbursement
  • Vision insurance

Schedule:

  • 8 hour shift
  • Monday to Friday

Supplemental Pay:

  • Bonus pay

COVID-19 considerations:
PolyPeptide has taken necessary safety precautions, aligned with the CDC guidelines for ensuring safety and social distancing.

Education:

  • Bachelor's (Required)

Experience:

  • Quality assurance: 3 years (Required)

Work Location: One location

Posted
11/22/2021
Salary Range
$49,000.00 - 86,000.00
per Year
Salary range estimated by
Location
San Diego, CA 92126, US
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