The HireMojo Team
Boston Analytical is a premier cGMP compliant laboratory, FDA and DEA registered for pharmaceutical analytical testing. We provide the highest quality analytical testing services to Pharmaceutical, Biopharmaceutical, and Medical device companies worldwide. Since 1987, Boston Analytical has been and remains dedicated to customer satisfaction, and to the fast and accurate analysis of our clients' products.
The Compliance Specialist has oversight responsibilities for the internal and external auditing programs. This includes hosting of audits from clients and regulators, including audit preparation and follow-up activities. The Compliance Specialist also acts as lead investigator for audits conducted by Boston Analytical (e.g. internal and supplier audits).
PRIMARY DUTIES AND RESPONSIBILITIES
- Oversight of the internal audit program for both GMP and ISO compliance
- Generation of the internal audit schedule
- Coordinate audit activities with applicable departments
- Track audit activities and follow-up requirements
- Work with QA Management to determine acceptance of audit responses
- Scheduling and hosting of client and regulatory audits/inspections
- Audit preparation activities
- Hosting of audits
- Authoring audit responses and coordinating associated activities
- Lead supplier auditing program
- Schedule audit activities to align with supplier qualification program requirements
- Work with QA Management to determine acceptance of audit responses and questionnaires
- Perform routine review of suppliers
REQUIREMENTS & QUALIFICATIONS
Qualifications include a Bachelor’s degree in a related discipline with 3+ years with a combination of QA/QC and auditing experience in the pharmaceutical industry.
Strong familiarity with regulatory/compliance environment (cGMP, GLP) associated with biotechnological, parenteral drug manufacture and/or medical device production.
Experience in root cause analysis, risk management, and corrective/preventative action development.
- Enthusiastic, team player, collaborative across all departments to achieve the common goals.
- Ability to focus on internal processes while maintaining focus on client needs.
- Ability to work in a fast paced, dynamic environment.
- Experience with LEAN implementation.
- Familiarity with laboratory information management systems (LIMS).
- ISO 17025 or 9001 experience and knowledge.
- Demonstrated ability to foster a Quality Culture across the organization.
- Lead Auditor experience and/or CQA certification.
Boston Analytical is a growing pharmaceutical contract lab providing quality Analytical and Microbiological testing services. We are known for our quality and believe our success is driven by our employees. We provide our employees with a state-of-the-art work environment, excellent benefits and opportunities for development.