Manufacturing Superintendent

• →Overseeing team leads in accomplishing overall departmental production needs and reviewing work to ensure consistency
• →Mentoring members of the production group and providing constructive input
• →Reviewing the completed BPRs (ensuring all QCs, deviations, cleaning sheets, etc. are attached to the BPR, BPR lines are signed and verified, QA review items are resolved, and label requests have been completed)
• →Assisting in updates on batch production records (BPRs) to optimize process efficiencies and to assist in developing new BPR’s or work instructions
• →Supporting manufacturing schedules through appropriate documentation and staging requestsEnsuring material and/or solvent counts are completed upon request
• →Ensuring the equipment and processing areas are in a ready state to meet the posted schedule
• →Identifying, troubleshooting, and resolving equipment, process and facility issues as well as contributing to process risk assessments
• →Participating in the hiring, training, and performance evaluation of employees
• →Participating in regulatory inspections and audits
• →Interacting with multi-discipline units and personnel to ensure product quality and on-time delivery is adhered to
• →Flexibility for after-hours consultation during manufacturing activities or during infrequent production activities will be required
• →Participating in client meetings and teleconferences
• →Providing guidance and oversight to a team of employees

 ·          Ability to work 12-hour rotating shifts.

 ·          Heavy lifting required (50 lbs.).

 ·          Ability and willingness to work after hours and weekends if required.

Required to use a respirator.

• Post-Secondary Degree or Diploma in a scientific field
• Two years demonstrated leadership experience
• Two years GMP experience, protocols and FDA guidance
• Five years of related technical experience