Quality Control Manager

• The employee should successfully meet schedules in a high quality and professional manner and ensure work areas conform to cGMP regulations, Standard Operating Procedures and Company Policies.
  Specifically, while working independently, this person will perform the following duties adhering to written Standard Operating Procedures (SOPs), USP/NF, or written work instructions:
• Manage all internal and outsourced QC laboratory operations. Provide the primary technical support for the QC laboratory and ensure that all testing and investigation, deviations are performed in a high quality and timely manner.
• Responsible for managing stability programs, and the release of drug substance, and finished drug products.
• Responsible for managing QC department validation and calibration activities.
• Coordinate QC support activities of the sterile manufacturing areas, such as environmental monitoring, in-process sampling, utility sampling and formulation.
• Coordinate QC personnel activities to ensure that all testing and calibrations are completed according to schedule and meet all cGMP requirements.
• Responsible for monitoring instrument qualifications and ensuring that qualifications of analytical instruments are up to date and meet regulatory requirements.
• Develop test protocols, review and write technical reports, write SOP s, and review stability data.
• Work closely with QA to implement procedures in compliance with regulatory requirements.

• Manage direct reports for administrative/HR purposes such as time off and sick days.
• Responsible for interviewing, hiring, coordinating training, and terminating direct reports. Perform annual reviews for all direct reports. In addition, execute disciplinary actions, as needed.
• Perform review of laboratory notebooks for accuracy and compliance to the analytical method.
• Write and perform review of QC reports.
• Review investigations, deviations, and CAPAs; coordinate with impacted departments (client) and QA; create and implement appropriate corrective and preventative actions.
• Set annual goals with supervisor to improve job and individual skills and abilities; Maintain a high level of quality of product and improved established efficiency and yield standards
• Other duties as assigned by management

• Knowledge of sterile manufacturing process and procedures (Preferred)
• Knowledge of microbiological and analytical laboratory techniques
• Knowledge of sterile techniques used in the laboratory
• Experience working in QC laboratory
• Ability to learn new laboratory equipment and techniques
• Excellent verbal and written communication skills
• Knowledge of cGMPs, USP/EU regulations, and ICH guidelines
• Analytical reasoning, root cause analysis and problem solving
• Ability to manage direct reports
• Technical writing: write, read, understand, and interpret technical writing and instructions
• MS Office skills; particularly Word and Excel
• Math and calculation skills
• Multitask and coordinate with operations and quality assurance simultaneously
• Work with a wide range of people to solve problems and resolve issues
• Work in a fast-paced environment
• Ability to maintain flexible task schedule and workflow

• Highly detail oriented with good record keeping skills
• Excellent people skills, with experience collaborating in a multi-disciplinary, diverse and dynamic team

• Bachelor s Degree in Chemistry, Biochemistry, Biology, Microbiology, Engineering or equivalent with 10 years of experience in sterile pharmaceutical and/or biotechnology manufacturing
• Master s Degree in Microbiology, Biology, Engineering, Chemistry, Biochemistry or equivalent with 7 years of experience in sterile pharmaceutical and/or biotechnology manufacturing (Preferred)
• Minimum of 5 years direct experience with supervision

• Lift up to 35 lbs.
• Ability to work standing in laboratory for an 8-hour shift