Our client is seeking a Laboratory Manager to oversee the daily operations of a laboratory to ensure a safe, efficient, and compliant working environment. This role is responsible for supervising laboratory personnel, managing equipment and inventory, ensuring adherence to regulatory standards, and supporting projects by maintaining high operational quality.
Responsibilities- Maintain data integrity and ensure compliance with company procedures and specifications, FDA, cGxP, and QSR regulations.
- Perform reviews of test data, including overall documentation practices.
- Ensure that laboratory equipment is calibrated and maintained.
- Select and order new equipment and tools as necessary.
- Perform testing in a timely and appropriate manner to meet project schedules.
- Enforce the application of laboratory rules and procedures.
- Lead and organize all activities of the laboratory, including planning, organization of work, and reporting.
- Deploy environment, health, and safety policies to prevent accidents, safeguard the environment, and better control consumption and waste.
- Deploy applicable quality policies and procedures within the laboratory to ensure compliance with applicable regulatory requirements.
- Use sophisticated laboratory instrumentation and computer systems to collect and record data; may be required to serve as a system owner and conduct validations.
- Ensure adequacy between necessary skills and company objectives, including participating in the definition of recruitment needs, assessing employee performance, drawing up training plans, and managing the integration and training of new hires.
Qualifications- Bachelor's or Master's degree in Engineering, Science, or a related field.
- 7-10+ years of experience working in a laboratory environment for regulated industries such as pharmaceutical or medical device.
- 3+ years of lab operations and personnel management experience required.
- Experience with quality tools such as Measurement System Analysis, Gage R&R, and Design of Experiments.
- Experience with mechanical testing.
- Strong leadership and communication skills.
- Excellent organizational and time-management abilities.
- Knowledge of lab safety regulations and compliance requirements.
- Ability to troubleshoot equipment and process issues.
- Detail-oriented with strong documentation practices.
- Experience with laboratory information management systems is a plus.
LocationEmployee TypeCompensation & Benefits- Salary range: $110,000-$130,000 USD
- Health insurance
- Paid time off and holidays
- 401(k)
