Lab Manager

LAMPIRE Biological Laboratories, Inc.; Northern (KY); Hybrid; USD 60,000 - 85,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Life insurance

Disability insurance

401k with matching contribution and 2%

Job summary

Lampire Biological Laboratories, Inc. is seeking a quality/compliance professional to ensure regulatory standards are met and to lead training for department staff in a cGMP environment.

The role supports ongoing validations, change controls, and CAPA activities while coordinating with cross-functional teams. Responsibilities include maintaining facilities readiness, participating in internal and external audits, and promoting adherence to the company’s quality policy and SOPs.

Qualifications

• Minimum 3-5 years of relevant work experience.
• Good organizational skills with the ability to manage and prioritize multiple tasks and meet deadlines.
• Experience with cGMP quality systems and manufacturing operations.
• Ability to give directions, train others and communicate effectively both orally and written.
• Willing to hold all staff accountable and work with cross-functional teams.

Responsibilities

• Maintain compliance with internal and external regulatory standards and execute department responsibilities.
• Support production and quality activities as needed.
• Provide training for department/facility staff.
• Address facilities needs including equipment calibration, maintenance, pest management, environmental monitoring, and housekeeping.
• Ensure cGMP requirements are followed (vendors, expiry materials, calibrated/PM equipment, approved SOPs and specs, VAR/NCRs, and release of materials).
• Assist with Validations and Change Controls when needed.
• Support investigation reports as part of CAPA program.
• Assist with internal and external audits.
• Perform other duties as assigned.

Skills

Training others

Regulatory compliance

Communication

Multitasking

Team collaboration

Education

Bachelor's/Associates in science

Tools

Microsoft Word

Excel

Job description

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.