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Compliance Specialist

Company: Apex Systems
Location: Morrisville
Posted on: June 24, 2022

Job Description:

*** Apex Systems is now seeking a Sr. Compliance Specialist to come on-site in Morrisville, NC. Candidates must have at least 3 years of QA/Regulatory Affairs expereince, preferably in audit functions. Qualified candidates can send their resume directly to Serena at! ***Industry: Pharmaceutical Location: Morrisville, NC (on-site) Duration: 6 month contract to hireTerms: W2 Job SummaryThis position requires a good degree of initiative and independent judgment to resolve problems and create solutions. The work is complex and may or may not be covered by adequate procedures. Candidate should have ability to create process maps and develop/drive/implement improvement of critical Quality Systems and ensure compliance with applicable regulations and standards. Ability to use risk management tools in the design of solutions. Act as a resource for internal and external customers with regard to Quality Systems issues. Able to lead and manage internal audits as well as customer audits. Comply with divisional and site Environmental Health and Safety requirementsSpecific Duties, Activities, and Responsibilities

  • Lead Internal Audit program to include scheduling, preparation, execution and post-audit activities (i.e. response and commitment tracking).
  • Support Customer Audits by participating and/or leading audits as needed.
  • Serve as support for multiple Quality Systems functions (e.g. Supplier Quality, Quality Agreements, Procedures)
  • Identify potential compliance issues and task corrective measures to prevent them, participating on assigned teams as required.
  • Support compilation and tracking of metrics related to Internal AuditsJob RequirementsEducation and Experience:
    • Bachelor's degree in Chemistry or related physical science from a four-year college/university or equivalent education and job experience
    • Minimum Ten (10) plus year's experience in an FDA regulated industry with a minimum three (3) years of experience in QA/Regulatory Affairs, preferably in audit functions
    • ASQ CQA, ISO 13485 Lead Auditor, or equivalent, strongly preferred
    • Demonstrated experience with leading or hosting internal/external audits.Knowledge, Skills and Abilities:
      • The employee must have a broad understanding of Quality Management Systems (e.g. Document Control, Deviation Management, Laboratory and Manufacturing Controls) and administrative practices and be able to function independently without close supervision
      • Requires knowledge of ICH Q8, Q9 and Q10
      • Requires knowledge of US and EU cGMP Regulations (i.e. 21CFR Part 4, 21 CFR Part 11, 21CFR 58, 21CFR 210 and 211).
      • May require some customer interface
      • Requires interaction cross-functionally at all levels within the organization
      • May require presentation of information to employees and/or customers
      • Requires excellent written and verbal communication skills
      • Provides information in a tactful and professional mannerPhysical Requirements:
        • Individual may be required to sit, stand, walk regularly and occasionally lift 0-15 pounds.
        • Specific vision requirements including reading of written documents and use of computer monitor screen frequently.Working Conditions and Environment:
          • The position will be stationed in an office environment
          • Flexibility required to work outside normal working hours of 8:00 a.m. - 5:00 p.m.Hiring Preferences: Education and Experience:
            • Bachelor's degree in Chemistry or related physical science from a four-year college/university or equivalent education and job experience Knowledge, Skills and Abilities:
              • Some experience/knowledge with Medical Device regulations (21CFR Part 820) preferred

Keywords: Apex Systems, Cary , Compliance Specialist, Other , Morrisville, North Carolina

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