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QA Systems Specialist

Job Post Index 2446FE-Sy##
Location Rockville, MD
Description: Description
  • Management Monitoring, Independent Business Monitoring and Audit Readiness.
  • Provide guidance to the site in the area of cGMP compliance.
  • Perform verification steps for applicable CAPA to ensure “in-place”, “in-use” and “effective” as it pertains to auditing practices.
  • Pre-approves and routes documents for review and approval in the electronic Quality Management System (Veeva).
  • Maintains the document archival room.
  • Responsible for filing and maintenance of all controlled documents and records.
  • Ensures files are accurate and easily retrievable.
  • Maintains internal and external files for archiving and record retention programs.
  • Provides clerical and administrative support related to documentation processes and systems.
  • Creates logbooks to be used in production (Lab Notebooks, Logbooks and Documents).
  • Scans, verifies and archives documentation and records
  • Performs general word processing tasks.
  • Checks format and conformance to document templates.
  • Ensure the correct and timely input of database entries.
  • Participates in function meetings.
  • Notifies manager of compliance questions and issues.
  • Provides additional support and assistance on tasks and projects as directed by management
  • Assists in the preparation for and participation in regulatory agency inspections, corporate and customer audits.
  • Performs audit observation follow-up for global quality assurance audits and regulatory inspections
  • Participates in applicable root cause analysis teams to review and agree to the CAPA plan, the CAPA performance measures and the assessment dates.
  • Verify that applicable CAPA has been delivered as committed and that the CAPA remains “in-place” and “in-use”.
  • Assists in creating and administering training on procedures and GMP topics.
  • Provide metrics to Manager and identify potential trends and gaps.
Skills: Qualifications
  • Minimum of Bachelor of Science in Business, Technical or Scientific Discipline.
  • Thorough technical and regulatory knowledge of current pharmaceutical manufacturing techniques and the applicable current regulatory and requirements.
  • Solid ethics and integrity; confidentiality, impartiality, independent, straight forward, and sensitivity to problems.
  • Excellent written and oral communication skills.
  • Must be proficient in MS Office Suite.
  • Must have a complete knowledge of current Good Manufacturing Practices, United States Pharmacopeia, current Code of Federal Regulations (21CFR parts 11, 210, and 211) and other DFA, European and global guidance’s
  • Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals.
  • Veeva Experience Preferred but not required

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