Job DescriptionPosition Purpose: The Lab Manager oversees 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.
KEY RESPONSIBILITIES/ESSENTIAL FUNCTIONS: - Maintains data integrity and ensures compliance with company procedures and specifications, FDA, cGxP, and QSR regulations.
- Performs reviews of test data, which includes overall documentation practices.
- Ensures that laboratory equipment is calibrated and maintained.
- Selects and orders new equipment and tools as necessary.
- Performs testing in a timely and appropriate manner to meet project schedules.
- Enforces the application of laboratory rules and procedures.
- Leads and organizes all activities of the Laboratory including planning, organization of work and reporting.
- Deploys environment, health and safety policies to prevent accidents, safeguard the environment and better control consumption and waste.
- Deploys applicable quality policies and procedures within the laboratory to ensure compliance with applicable regulatory requirements.
- Uses sophisticated laboratory instrumentation and computer systems to collect and record data. May be required to be a system owner and conduct validations.
- Ensure the adequacy between the necessary skills and the objectives of the company: participate in the definition of recruitment needs, assess employee performance, draw up training plans, manage integration and training of new hires
QualificationsPOSITION REQUIREMENTS: - Bachelor's or Master's degree in Engineering, Science or related field
- 7-10+ years of experience working in laboratory environment for the regulated industries of pharmaceutical or medical device.
- 3+ years of lab operations and personnel management is required
- Experience with quality tools such as Measurement System Analysis, Gage R&R and Design of Experiments
- Excellent interpersonal and organization skills
- Experience with laboratory information management systems a plus.
- Experience with mechanical testing
Skills & Competencies- 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.
Additional InformationPAY RANGE: $110,000 - $130,000 USD Salaried (This is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting. This range may be modified in the future.)
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