Quality Control Manager

The Quality Control Manager will provide leadership with responsibility for the development and maintenance of all required laboratory infrastructure, and the direct management and support of QC personnel. The Manager will ensure the efficient functioning of the laboratory, maintain compliance with industry regulations, manage resources, and foster a productive and safe work environment. Manage all quality-related activities related to raw materials and activities associated with QC external laboratories.

• Oversight on qualification, maintenance and calibration of laboratory equipment and related software
• Oversee lab safety and regulatory compliance, including management of chemical waste, reporting any safety incidents to EHS department, addressing any safety issues identified by EHS, and enforcing PPE policy and lab safety rules
• Management of lab consumables and chemical inventories supporting all QC testing services
• Performing periodic internal laboratory audits to ensure QC laboratory audit readiness
• Oversee daily scheduling of analyses, QC resource allocation, and release of raw materials, in-process controls, intermediates, and final API with the ability to prioritize projects as per internal/external customer needs
• Responsible for the timely review, reporting, and release of analytical data
• Setting and maintaining raw material specifications per internal procedures and current with various compendia (e.g. USP, ACS, NF, EP). Requires close collaboration with development and project management teams
• Maintain systems around the use of analytical contract laboratories including but not limited to packaging, labeling, shipment, receipt of data and qualification of laboratory
• Guides direct reports in setting goals aligned with business objectives. Delivers performance feedback to direct reports in a constructive manner, culminating in the annual review process.
• Provides assistance to new employees and other cross-functional departments
• Authors, updates, reviews, and manages standard operating procedures, reports and associated change control documentation that impact workflow and processes
• Write laboratory investigations and deviations and coordinate additional testing needs. Utilize root cause analysis tools to identify root cause
• Trains QC personnel regarding QC procedures and documentation, CGMP practices, and various ICH guidelines
• Recommends or developsimprovements in QCS methodology/processes and implementation of new procedures or change initiatives
• Track, trend, and report activity metrics
• Participate in project meetings as appointed by the Director of Quality
• Attend training and workshops for career development
• May serve as a proxy and interact productively with appropriate internal/external customers on behalf of the Director of Quality
• Perform additional responsibilities as assigned by the Director of Quality

• Bachelor’s degree (BS) or equivalent in a related science field from a Four-Year College or University and at least 5 years related experience and/or training in a CGMP laboratory environment, or high school diploma with ten to twelve years related experience and/or training in a CGMP laboratory environment
• Knowledge of laboratory and chemical principles, terminology, material, equipment, procedures, and techniques
• Knowledge and experience with various laboratory testing procedures such as spectroscopic, titrimetric, and chromatographic
• Knowledge and experience on the operation and maintenance of various standard laboratory instruments and equipment, including associated software programs
• Knowledge of the techniques required for general laboratory safety and the proper handling of hazardous materials
• Excellent and effective communication skills and the ability to interact with all levels of staff and with external contacts in a fast-paced and demanding environment
• Adherence to CGMP/cGLP and ALCOA regulations
• Proficient use of Microsoft Word, Excel and PowerPoint, and 21 CFR compliant chromatography data system software
• To perform this job successfully, an individual must be able to perform each essential duty satisfactorily
• Requirements listed above are representative of the knowledge, skill, and/or ability required; reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions
• While performing the duties of this job, the employee is frequently required to stand, use hand to finger, handle, or feel objects, tools, or controls; and reach with hands and arms
• Specific vision abilities required by this job include close vision, color vision, depth perception, and the ability to adjust focus