Job Description: Supervise and manage all personnel at the Pipersville Biotech Lab and support production requirements.
Responsibilities Include (but are not limited to): Ensure all requirements of the department are executed in a timely and compliant manner. This may include production and quality activities.
- Maintain compliance with internal and external regulatory standards.
- Serve as the example within the department upholding all Lampire's corporate policies, as well as the Quality Policy.
- Provide training for all department/facility staff.
- Ensure facilities needs are addressed in a timely manner which may include equipment calibration and maintenance, pest management, environmental monitoring and general cleaning and housekeeping.
- Ensure personnel are following cGMP requirements such as using material from approved vendors, using material that is within expiry, using equipment that is within calibration/PM, only using approved materials, using current approved versions of SOPs and client specs, requesting VAR and NCRs when needed, shipping only material approved for release etc.
- Initiates an assists with Validations and Change Controls, when needed.
- Assist in preparation of investigation reports as part of the Corrective and Preventative Action (CAPA) program.
- Assist with internal and external audits
- Other duties as assigned
Requirements:- Minimum 3-5 years of relevant work experience
- Good organizational skills with the ability to manage and prioritize multiple tasks and meet deadlines
- Windows based computer skills, familiarity with Microsoft Word and Excel
- Experience with cGMP quality systems and manufacturing operations
- Ability to give directions, train others and communicate effectively both orally and written
- Works well with personnel from other functional areas and is willing to hold all staff accountable
Education: Bachelors/Associates degree in science or similar field, or equivalent experience
Job Benefits: Lampire Biological Laboratories offers a competitive salary, medical, dental, life, disability insurances, 401k with matching contribution and profit sharing.
