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