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QA Systems Specialist
LanceSoft Rockville, MD

QA Systems Specialist

LanceSoft
Rockville, MD
  • Full-Time
Job Description
Company Info
Job Title: QA Systems Specialist
Duration: 6 -7 months, end date is FIRM
Location: Rockville, MD, 20852
Standard Day Shift (Mon-Fri; 40 hrs/wk; 8 hrs/day) roughly 8:00am4:30pm (1/2 hour lunch) with some flexibility
100% Onsite work (with COVID 19 practices in place; ie, wearing masks in the building is required)


Job Purpose:
  • 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

Key Responsibilities:
  • Acts as lead auditor during Rockville Internal audits
  • Generates and obtains approval for audit plan on an annual basis
  • Holds meetings as required to review audit plan, as well as holding meetings to review and explain audit findings with designated members of management
  • Issues internal audit reports using existing format
  • Reviews responses for adequacy and communicates discrepancies with responses to owners
  • Assists owners as required with responses to ensure corrective actions as committed are implemented
  • 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 as requested
  • Manages the site Self Inspection program
  • Acts as a student of current regulatory expectations and provides consultation to customers on interpretation of regulation and guidance published by regulatory agencies, industry and client
  • 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
  • Monitors and reviews performance measures to ensure CAPA effectiveness
  • Issues and Processes site requests (Lab Notebooks, Logbooks and Documents)
  • Maintains internal and external files for archiving and record retention programs
  • Assists in creating and administering training on procedures and GMP topics
  • Provide metrics to Manager and identify potential trends and gaps

Knowledge/ Education / Previous Experience Required:
  • Minimum of Bachelor of Science in Business, Technical or Scientific Discipline
  • Minimum 6 years knowledge of global regulatory expectations and internal quality management systems
  • Thorough technical and regulatory knowledge of current pharmaceutical manufacturing techniques and the applicable current regulatory and clients requirements
  • Developed auditing skills: developing an audit plan, preparing and using checklists, follow-up, documentation findings, etc.
  • Certification as a Quality Auditor is desirable
  • Excellent verbal/written communication and interpersonal skills; respect for people, sensitivity to cultural differences, active listening, succinct writing, decision making ability, objectivity, and assertiveness
  • Solid ethics and integrity; confidentiality, impartiality, independent, straight forward, and sensitivity to problems


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