Process Validation Specialist

Company: PolyPeptide Group
Location: Torrance
Posted on: August 2, 2022

Job Description:

PolyPeptide Laboratories Group - One of the world's largest companies specializing in the manufacturing of peptide and related compounds for research and pharmaceutical applications. - -More information is available at our website, www.polypeptide.com - - - - - - - - - -Job Title: -QA Process Validation Specialist -Job Overview: -The ideal candidate will partner with internal stakeholders (Product Development, Engineering, QC, QA and RA) coordination and managing projects. Must be a Team player and a trainer within the department. The position will report to the QA Manager, based in Torrance, California. -QA Process Validation Specialist - Responsibilities include, but are not limited to the following: -

• Draft, review, and approve API master batch records
• Primary resource, while partnering with product development, engineering, and the customer, to draft, review, and approve API process validation protocols and reports
• Draft, review, and/or approve annual product quality reports for API
• Apply statistical approach, such as process capability, DOE, control, etc. to the design of protocol and the analysis of data
• Support Engineering, Maintenance, and Production technical needs
• 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
  Position Requirements: -
  • Minimum Bachelors Degree in Chemical Engineering (preferred) or other life science
  • Three to Five years relevant experience
  • Six Sigma Green Belt or equivalent preferred, but not required
    -Salary: DOE -PolyPeptide Laboratories is an Equal Opportunity Employer. We offer excellent benefits including comprehensive Medical/Dental/Vision coverage, Employee Assistance Program, Life and Long-term Disability Insurance, Generous 401(k) Match, Profit Sharing, Paid Holidays, Vacation, Sick Days, FSA Account Programs, Student Loan Reduction Program, Tuition Reimbursement Program, Birthday-off & Birthday Cash, Gym Membership Assistance Program and our Fresh-Fruit Program.

Keywords: PolyPeptide Group, Torrance , Process Validation Specialist, Other , Torrance, California