Laboratory Manager

Lampire Biological Laboratories•Everett, PA

16h•Onsite

About The Position

The Laboratory Manager will supervise and manage all personnel at the Everett Lab and support production requirements. This role involves ensuring all departmental requirements, including production and quality activities, are executed in a timely and compliant manner. The manager is responsible for maintaining compliance with internal and external regulatory standards, upholding Lampire's corporate policies and the Quality Policy, and providing training for all department/facility staff. Key responsibilities also include addressing facility needs such as equipment calibration and maintenance, pest management, environmental monitoring, and general cleaning and housekeeping. The manager ensures personnel adhere to cGMP requirements, initiates and assists with Validations and Change Controls, aids in preparing investigation reports for the Corrective and Preventative Action (CAPA) program, and assists 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.
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.
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.
Initiates and 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.