QA Quality Systems Specialist

Company: Polypeptide Group
Location: Torrance
Posted on: January 16, 2022

Job Description:

PolyPeptide Laboratories Group - One of the worlds 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.comJob Title:QA Quality Systems SpecialistJob Overview:Work directly with the Manger, Quality Assurance (Compliance) to maintain, help develop and implement all aspects of a proactive Quality Assurance Systems. The systems (quality policies and procedures) must adhere to FDA and global regulatory organizations.Assure compliance with FDA & EU regulations, ICH guidelines and State of California regulations.Quality Systems Specialist responsibilities include, but are not limited to, the following:

• Participate and contribute through team functions such as supplier audits, annual product review, change control, CAPA, complaint handling, document control systems, and cGMP training of employees. Back up activities of Quality Assurance Specialist (Operations) which includes working on: deviations, batch record review, clinical and commercial product release.Entering data into databases in accurate and timely manner
• Insure Quality System, cGMP and ICH guidelines are followed on site.Help with 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, Manufacturing, Development, Marketing as well as Corporate Quality on customer projects, regulatory submissions, and harmonization of PPL Groups Global Quality standards across PPL Group sites
• Maintain our successful track record with FDA and other regulatory agencies
• Perform other duties as assigned
  Position requirements:
  
  • Minimum associate undergraduate degree in Chemistry, Biology orChemical Engineering.Prefer a BS or Masters in chemistry, biology, pharmacy or engineering
  • Minimum of one to three years of experience in quality assurance, quality control and compliance in the cGMP active pharmaceutical ingredient contract manufacturing industry or pharmaceutical company that internally produces their APIs
  • Experience in FDA, EMEA inspections with documented successful outcomes
  • Demonstrated ability to apply comprehensive, in-depth understanding of pharmaceutical industry regulatory compliance with emphasis on cGMP, IND, and NDAs
  • Excellent technical writing skills and effective communication skills needed
  • Experience in all aspects of Quality Assurance from preclinical to commercial product phases (phase appropriate cGMPs)
  • Ability to juggle multiple tasks, deadlines and priorities.Must collaborate across organization and functional boundaries including customers as a team player and occasional team leader
    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.by Jobble

Keywords: Polypeptide Group, Torrance , QA Quality Systems Specialist, Other , Torrance, California