Under minimum supervision, ensures compliance to cGMP regulations in
manufacturing area including all documentation complying with the Company’s Standard
Operating Procedures (SOPs), governmental regulations and other requirements where
applicable. Facilitates communication between departments to ensure a smooth flow of materials and release. Review and release raw, intermediate and finished materials.
Essential Job Functions
procedures, and state, federal and local laws.
- Carries out lead responsibilities in accordance with the organization’s policies,
Procedures (SOPs), current Good Manufacturing Practices, (cGMPs) and Company
- Assists in the training of new auditors in job duties according to Standard Operating
their corresponding batch records.
- Review and release raw, intermediate and finished materials and products, as well as
R&D support documentation of products and materials.
- Interface with Transdermal Development R&D support and Analytical Services.
- Audit data from Analytical Services, vendors’ certificates of analysis, and other relative
finished product reports, assuring compliance with cGMPs, current Good Laboratory
- Prepare, revise and verify SOP, QSMS, IQ/OQ, Swab Data and clinical releases.
- Monitor environment as needed.
- Maintain Quality Assurance documentation files, databases and logs.
- Assist in preparing budgets and reviews.
- Conduct final audit of Laboratory Service Reports for raw materials, in-process and
Procedures (cGLPs), test methods and SOPs and prepare documentation for release.
methods and SOPs.
- Conduct final audit of stability reports assuring compliance with cGMPs, cGLPs, test
documents for release, assuring compliance with cGMPs and SOPs.
- Conduct audits of other documents as directed by the Supervisor and prepare these
Reports and trend analysis as required.
- Interface with other department’s personnel to complete job duties.
- Initiates and completes Quality Audit’s computer data input for Laboratory Service
problem resolution, planning, and work assignment delegation.
- Participates in and provides training programs for the development of successful working understanding of materials presented and become more proficient in assigned duties and tasks.
- Provides support, direction and coaching to team members in the areas of training,
- Ensures project deadlines and performance standards are established and met.
- Ensures compliance with all Company policies and procedures, including safety rules and regulations.
- Performs related duties as assigned.
and other regulatory requirements.
- Current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA),
- Advanced principles of auditing and performance evaluations.
- AQL sampling and inspection principles and techniques.
- Principles of mathematical and statistical computation and analysis.
- Business, scientific and personal computer hardware and software applications.
- Business English usage, spelling, grammar and punctuation.
- Pharmaceutical principles, practices and their applications.
- Leadership and training methods and techniques.
- Current Company policies, practices and procedures, including safety rules and
projecting consequences of proposed actions and implementing methods, procedures
- Observing, analyzing and troubleshooting problems, identifying alternative solutions,
and techniques for resolution to support Company goals.
certificates of analysis and conformance and other applicable data sources
- Reading, interpreting records, reports, business, personal and scientific computer data,
- Responding to inquiries from management, employees and regulatory agencies.
- Communicating clearly and concisely, both orally and in writing.
- Operating scientific, business and personal computers.
- Interpreting and applying Federal, state and local policies, procedures and regulations.
- Establishing and maintaining cooperative working relationships with others.
- Ensuring compliance with all Company policies and procedures, including safety rules
Three (3) years pharmaceutical quality assurance auditing experience. An equivalent combination of education and experience may be substituted.
Bachelor’s Degree in Science or related field from an accredited
college or university.