QC Chemistry Supervisor
3 days ago
Tonawanda
Job DescriptionSalary: 65K-75K DOE 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 Bachelors 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