Laboratory Manager

ESSENTIAL DUTIES AND RESPONSIBILITIES:
Plan, direct and coordinate the operational activities of the microbiology and analytical labs.
Maintain a safe and healthy work environment by establishing and enforcing organizational safety standards and adhering to legal regulations.
Ensure quality systems are being applied in the performance and documentation of lab studies and production processes.
Ensure compliance with applicable quality and regulatory requirements (qualified/trained staff, validated equipment, proper documentation practices, etc.).
Ensure test methods and production processes meet specified protocol or SOP requirements, are scientifically sound and are performed error-free.
Oversee testing of water (USP), raw materials, and finished goods.
Evaluate environmental monitoring data and conduct prep, AMPET, and microbial limits testing per USP requirements.
Track, monitor, recommend and implement improvement activities to achieve annual first pass yield objectives.
Participate in audits by customers or regulatory agencies.
Address observations or recommendations as well as implement corrective/preventive actions as needed.
Notify Director of Quality of test results and assist in the interpretation of what the results mean and how to proceed.
Assist the Laboratory and Operations with the interpretation of test results and to determine additional steps to be taken, as needed.
Perform a failure investigation identifying root cause and take corrective/preventive action in the event of a failure.
Work with peers (other department managers) to standardize work practices throughout the organization.
Ensure compliance with GMP, QSR/ISO, FDA, OSHA, and all other regulatory requirements, in accordance with company policy.
Adhere to company safety requirements.
Meet customer expectations for timeliness of lab studies and product shipments as measured by on-time percentage.
Analyze and resolve internal and/or external delays as well as identify trends, recommend improvements and implement improvement activities to achieve annual on-time objectives.
Provide exceptional customer service.

General requirements :
Bachelor’s degree in Chemistry, Microbiology, or a related field.
3-5 years lab management experience.
Detailed knowledge of biohazard and USP requirements.
Minimum 3 years experience in an FDA regulated environment.
Experience with ISO, GMP and/or GLP standards required.
Prior supervisory experience.
Experience with laboratory practices including pH testing and titrations.
Knowledge of the scientific method, chemical products, test procedures, and composition of raw materials.
Knowledge of chemical terminology and units of measure.
Ability to initiate, perform, and complete reports in a timely manner.
Ability to work independently with little direction in a fast paced environment.
Good interpersonal skills.
Ability to schedule projects and meet tight deadlines.
Proficient in Microsoft Office.

Hiring Process:
Email resume' to mhorning@unicep.com