Position Summary:
The QC Chemistry Supervisor position is a hands-on position responsible for the oversight of the daily operations of the chemistry laboratory analyses and personnel performing chemical analysis and stability scheduling/testing. The supervisor will coordinate laboratory throughput and compliance activities, support development and validation activities and manage the stability program. Ensuring the maintenance of a cGLP laboratory and keeping up with regulatory requirements.
Essential Functions:
Job duties include the review and/or approval of required documentation in a cGMP 503B outsourcing facility, ensuring compliance with regulations, policies, and procedures.
Primary responsibilities:
- Execute, supervise, and review in-process, development, validation, release and stability testing on batches including, but not limited to, pH, Color and Clarity, Assay, etc.
- Review/approval of release/stability specifications and stability protocols.
- Assist in retrieval and compilation of quality metric data.
- Point of contact when Quality Control Manager is unavailable.
- Design and implementation of personnel schedule to meet production needs and support training requirements.
- Author, review, and/or approve laboratory documents (i.e., protocols, reports, SOPs, test methods, technical documents, and risk assessments)
- Assists in evaluation of new and existing analytical methods being transferred to or from the site.
- Contributes, supports, and leads writing of OOS/OOT and nonconformance investigations.
- Drives 5S and Lean projects.
- Support internal and external audits of facility.
- Ensures adherence to all company policies and procedures relating to current Good Manufacturing Practices, Standard Operating Procedures and Health, Safety and Environmental Protection regulations.
- Support for junior analysts and chemists on proper equipment maintenance and troubleshooting failures.
- Working as an effective team member to meet departmental objectives, sharing knowledge with team members and across the laboratory.
- Promotes and maintains a safe, healthy working environment by instructing and enforcing compliance with established safe work practices and procedures.
- May perform other duties as assigned.
Education and Experience:
- A minimum of Bachelor's degree in Biology, Chemistry, or other related science is required.
- A minimum of 5 to 7 years of pharmaceutical laboratory experience is required.
- 1-3 years of Supervisory experience preferred.
- Knowledge and understanding of FDA cGMP, CFR Parts 210 and 211, USP Chapters / Monographs, and ICH Guidelines.
- Knowledge of statistical tools and trending data analysis
- Experience with trending and maintaining product stability
- Experienced in writing OOS/OOT and/or deviation investigations
- Experience in Analytical Quality Control, method development, or a technical support function is desired
- Proficiency using LIMS, electronic Quality Management Systems
- Experience with HPLC and chromatographic data software
Knowledge, Skills and Abilities:
- Strong attention to detail with the ability to follow standard operating procedures.
- Able to adapt and respond quickly in a fast-paced environment.
- Ability to work independently.
- Able to communicate in a professional manner and interact with management, clients, and vendors on routine basis.
- Excellent organizational, verbal, and written communication skills.
- Must be organized and flexible with an ability to handle multiple work assignments.
- Good conflict resolution abilities to improve organizational productivity
- Good interpersonal skills to identify and establish a purposeful team culture
