Laboratory Manager

Lampire Biological Laboratories•Everett, PA

2d•Onsite

About The Position

Supervise and manage all personnel at the Everett Lab and support production requirements. 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.

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

Responsibilities

Supervise and manage all personnel at the Everett Lab and support production requirements.
Ensure all requirements of the department are executed in a timely and compliant manner, including production and quality activities.
Maintain compliance with internal and external regulatory standards.
Uphold all Lampire's corporate policies and the Quality Policy.
Provide training for all department/facility staff.
Ensure facilities needs are addressed in a timely manner, including equipment calibration and maintenance, pest management, environmental monitoring, and general cleaning and housekeeping.
Ensure personnel are following cGMP requirements.
Initiate and assist with Validations and Change Controls.
Assist in preparation of investigation reports as part of the Corrective and Preventative Action (CAPA) program.
Assist with internal and external audits.
Perform other duties as assigned.