Lab Operations Manager - cGMP & Compliance Champion

LAMPIRE Biological Laboratories, Inc.; Pennsylvania; Hybride; USD 80 000 - 110 000; Plein temps

Avantages offerts par ce poste

Medical insurance

Dental insurance

401k with match

Profit sharing

Résumé du poste

Lampire Biological Laboratories, Inc. in Everett, WA, is seeking a Laboratory Operations Manager to lead laboratory production, drive operational excellence, and champion continuous improvement.

This role supervises all lab personnel at the Everett Lab, ensures cGMP compliance, supports audits, and trains staff to uphold Lampire's quality and safety standards. Requirements include a Bachelor’s or Associate degree in science (or equivalent) and 3–5 years of relevant experience; a competitive

Qualifications

• Minimum 3–5 years of relevant work experience.
• Experience with cGMP quality systems and manufacturing operations.
• Ability to train others and communicate effectively.
• Ability to manage multiple tasks and meet deadlines.

Responsabilités

• Supervise and manage all personnel at the Everett Lab and support production requirements.
• Ensure all department requirements are executed in a timely and compliant manner (production and quality).
• Maintain compliance with internal and external regulatory standards.
• Serve as the example within the department upholding corporate policies and Quality Policy.
• Provide training for all department staff.
• Address facilities needs including equipment calibration, maintenance, pest management, and environmental monitoring.
• Assist with Validations, Change Controls, CAPA investigations, and audits.

Connaissances

Leadership

Training staff

Regulatory compliance

Organizational skills

Effective communication

Cross-functional collaboration

Windows & Office

Formation

Bachelor's/Associate in Science

Outils

Microsoft Word

Microsoft Excel

Description du poste

Are you looking to increase your impact on life sciences? Lampire Biological Labs is a premier biotech life science company dedicated to providing biological reagents to the pharmaceutical, diagnostic, and biotech industries and is seeking a motivated Laboratory Operations Manager to lead laboratory production, drive operational excellence, and advocate for continuous improvement. If you thrive in a fast-paced environment, take pride in running a compliant facility, and love developing talented teams, this is your opportunity to make a mark.

Why Join Us? Lampire offers competitive compensation, comprehensive health and retirement benefits, and an environment where operational initiative is recognized and rewarded.

Job Description: Supervise and manage all personnel at the Everett 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.

Lampire Biological Labs, Inc. is an equal opportunity employer. All qualified applicants receive consideration for employment without regard to race, color, religion, sex, or national origin.