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Quality Supplier Specialist

Company: Apex Systems
Location: Harmans
Posted on: June 13, 2021

Job Description:

Apex Systems has an immediate need for a Quality Supplier Specialist in the Harmans, MD area.

Responsibilities of Quality Supplier Specialist:

  • Supports management of suppliers through various systems (supplier qualification audits, change notification, periodic evaluation, re-assessments).
  • Helps identify compliance risks and works cross-functionally to identify and implement resolutions. Escalates significant compliance and/or business risks to management.
  • Maintains, analyzes and develops plans for improving quality metrics for Supplier Management and Internal Auditing programs.
  • Supports periodic Internal Audits of all functional groups.
  • Performs follow-ups to ensure action items from responses to internal and external audit observations are complete.
  • Assists with internal auditing schedules to assure adherence to internal operating procedures and GMP regulations.
  • Supports monitoring of internal audit commitments, ensuring sustainable compliance.
  • Stays current in GXP expectations, including FDA, EU and other relevant foreign regulatory bodies, guidance documents (i.e.: ICH, PTC, ISPE, etc.), and best industry practices.
  • Supports regulatory inspections as necessary.
  • Build and maintain successful cross-functional relationships with internal customers such as Manufacturing, Analytical, Quality Control, and Facilities Engineering.
  • Ability and willingness to work in a fast-paced environment.
  • Excels at multi-tasking and responding to Compliance Management requests to shift focus between Internal Audit and Supplier Management programs.

Required Education/Experience of Quality Supplier Specialist:

  • Bachelor's degree in biological science or technical discipline.
  • Minimum 2+ years' experience in GMP pharmaceutical, biologics and/or vaccine manufacturing.
  • Knowledge and expertise in principles and practice of current Good Manufacturing Practices (GMPs) from development through commercial applications.
  • Knowledgeable of FDA and EU regulations regarding the manufacture of biologicals including regulatory inspection experience.
  • Knowledge and experience in auditing Drug Substance manufacturing, Formulation/Fill finish manufacturing, and Material suppliers.
  • Excellent multi-tasking, analytical, organizational and leadership skills.
  • Ability to troubleshoot, identify root cause and systematically resolve problems.
  • Proficient in Window based software to include Excel and Word. Ability to adapt to changing software programs.
  • Ability to communicate clearly and effectively with all levels of the organization.
  • Ability to use MS TEAMS efficiently to communicate
  • Ability to work remotely and on-site

EEO Employer

Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at employeeservices@apexsystemsinc.com or 844-463-6178.

Keywords: Apex Systems, Baltimore , Quality Supplier Specialist, Other , Harmans, Maryland

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