Quality Assurance Specialist-Operations Job Vacancy in PolyPeptide Group San Diego, CA 92126 – Latest Jobs in San Diego, CA 92126 – updated today
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Company Name : PolyPeptide Group
Location : San Diego, CA 92126
Position : Quality Assurance Specialist-Operations
Job Description : 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
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