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Sr. QA Specialist - Supplier QualityPCI TRGR Penn Pharmaceutical Services Ltd • Bedford, Texas, United States
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Sr. QA Specialist - Supplier Quality

PCI TRGR Penn Pharmaceutical Services Ltd
  • US
    Bedford, Texas, United States
  • US
    Bedford, Texas, United States
Jetzt Bewerben

Über

Position Title: Sr. QA Specialist – Supplier Quality Location: Bedford, New Hampshire Department: Quality Assurance Reporting To: QA Dir, Quality Systems & Compliance Responsibilities Responsible for compliance relative to the overall Supplier Qualification Program by performing supplier audits to evaluate compliance to standard operating procedures, quality and regulatory standards and is responsible for creating and issuing audit reports. Responsible for follow up and tracking of supplier audit observations to assure timely closure. Monitor and communicate supplier change notifications and manage supplier non-conformance and complaint handling. Responsible for reviewing all audit responses to assure non-recurrence of deficiencies. Maintain, trend, analyze and report quality metrics as it relates to supplier audits and performance. Drafting, review, and management of supplier quality assurance agreements (QAA's) and non-disclosure agreements. Provide support for Quality Council meetings. Provide support during FDA and other regulatory agency inspections. Complete assignments and work independently without appreciable direction. Writes and revises QA Standard Operating Procedures (SOP). Support continuous improvement initiatives. Performs other duties as assigned. Qualifications Bachelor of Science Degree preferred with 15+ years in a QA GMP environment; alternatively, Master’s Degree with 10+ years of experience in a QA GMP environment. (High School diploma with 20+ years of progressive experience in QA GMP environment). Exceptional organizational skills. Excellent interpersonal skills and the ability to communicate well orally and in writing. Proficiency in MS Office including Word, Excel, Access and Visio. Excellent verbal and written communication skills required. Experience with GMP quality systems in a pharmaceutical/biotech/medical device environment is a must. Thorough knowledge of FDA regulations (i.e., 21CFR Part 210, 211 & 820) Guidance's, and ICH is required; EMEA and other agency regulations. Auditing certification preferred (i.e., ASQ, CQA or similar). Experience working with cross-functional teams, including giving training and/or presentations to large groups. Detail oriented and a results driven team player. Ability to work in a dynamic, fast paced work environment. Honesty, integrity, respect and courtesy with all colleagues. Creative with the ability to work with minimal supervision and balanced with independent thinking. Resilient through operational and organizational change. Equal Employment Opportunity (EEO) Statement: PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
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  • Bedford, Texas, United States

Sprachkenntnisse

  • English
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