Job Description- Applies GMP/GLP in all areas of responsibility, as appropriate
- Serving as an audit host / escort
- Answering questions about laboratory and quality systems, and regulatory compliance
- Taking notes throughout an Audit visit to document the scope of the audit and
- items that need to be addressed
- Communicating audit issues to senior management
- Providing formal written responses to client audit reports
- Ensuring follow-up to cited items is performed in a timely manner
- Diagnose problems, solve simple problems, and suggest solutions to complex problems in the professional area
- Keep oneself and peers abreast of current developments and trends in the professional area by reading and understanding internal procedures, attending training sessions, by writing/revising SOPs (as required), and by assisting Group Leader/Principal Specialists in training new employees
- Exercise discretion and independent judgment with respect to matters of significance directly related to the management or general business operations through the data review process
This role will be directly involved in Client Audits. Clients place great importance on compliance with applicable regulations, data quality, and project requirements and choose to audit our laboratory to confirm that their objectives are being met. Members of the Quality Assurance (QA) Department usually play a key role in these audits. Visits by clients can range anywhere from a tour (to verify facilities and instrumentation) to an intensive inspection of technical operations, procedures, and regulatory compliance.
QualificationsBasic Minimum Qualifications:- Bachelor's degree in a science-related field or equivalent directly-related experience (two years of directly related industry experience is equivalent to one full-time year of college in related major)
- Minimum of three years of Pharmaceutical industry experience with knowledge of regulatory requirements
- Computer skills including word processing, spreadsheets, PowerPoint and database
- Experience with cGMP and/or FDA regulated environments
- Authorization to work in the United States indefinitely without restriction or sponsorship
Preferred Qualifications: - Technical writing experience
- Previous experience in client audits as well as internal audits
- Previous experience in Pharmaceutical Quality Assurance or Regulatory Compliance
Additional InformationPosition is
Full-time, Monday-Friday, 8 a.m.-5 p.m., with overtime as needed. Candidates currently living within a commutable distance of Lancaster, Pennsylvania are encouraged to apply.
Excellent full-time benefits including:
- Comprehensive medical coverage, dental, and vision options
- Life and disability insurance
- 401(k) with company match
- Paid vacation and holidays
