Laboratory Manager

LAMPIRE Biological Laboratories, Inc.; Northern (KY); Hybrid; USD 65,000 - 90,000; Full time

Benefits offered by this job

Competitive salary

Medical insurance

Dental insurance

Life insurance

Disability insurance

401k with matching

Profit sharing

Job summary

LAMPIRE Biological Laboratories, Inc. in Kentucky seeks a Quality Assurance/Compliance professional with 3–5 years of relevant experience to support production and quality activities in a regulated setting.

You will ensure regulatory compliance, manage equipment calibration and maintenance, environmental monitoring, and routine cleaning while training staff. The role includes supporting validations, change controls, CAPA, audits, and cross‑functional collaboration to uphold Lampire's Quality

Qualifications

• Minimum 3–5 years of relevant work experience.
• Strong organizational skills with ability to manage multiple tasks and meet deadlines.
• Experience with cGMP quality systems and manufacturing operations.

Responsibilities

• Ensure department compliance with regulatory standards and timely execution of duties.
• Provide training for department staff and uphold Lampire's Quality Policy.
• Address facilities needs including calibration/maintenance, environmental monitoring, pest management, and cleaning.
• Adhere to cGMP requirements: approved vendors, in-date materials, calibrated equipment, current SOPs and client specs.
• Assist with validations and change controls as needed; support CAPA investigations.
• Assist with internal and external audits; perform other duties as assigned.

Skills

Attention to detail

Organizational skills

Written and verbal communication

Training others

Team collaboration

Education

Bachelor's/Associates degree in science or similar

Tools

Microsoft Word

Microsoft 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.