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Laboratory Supervisor

5 hour ENERGY®

This is a Contract position in Ashtabula, OH posted November 27, 2022.

JOB SUMMARY: The Lab Supervisor is responsible for the day-to-day implementation, support and sustainment of the laboratory systems.

This position ensures that processes needed for the laboratory system are established, implemented and maintained in accordance with cGMPs, 21 CFR Parts 110, 111, 117 and other applicable statutory and regulatory requirements.

The Lab Supervisor will be responsible for the performance management of up to 6-12 lab technicians.

RESPONSIBILITIES & DUTIES: Primary duties and responsibilities include performance and/or management of the following: Sustain Laboratory Systems to compliance with 21 CFR Parts 110, 111, and 117 requirements and other applicable regulations (e.g.

USP, Health Canada, Europe, Japan, etc.).

Evaluate and report on the status, adequacy and effectiveness of the laboratory system through data and trend analysis of key quality and performance indicators and report to senior management.

Sustain and approve changes to the laboratory systems that include but not limited to Document Control, OOS, Change Control, Validation, Calibration, Instrument Maintenance and other Laboratory Controls etc.

Develop, review and approve cGMP documentation for the laboratory such as but not limited to procedures, training materials, testing protocols, methods, instrument qualifications and method validations.

Author, review and/or provide oversight of the analytical method development and validation process for existing and new products.

Oversee the continuous improvements of existing methods.

Subject Matter Expert, Technical Leader and trainer for analytical methodologies for Lab Technicians.

Implement new analytical technologies as needed to support existing and new products.

Support and facilitate regulatory audits such as FDA, Canada, Europe, and/or Asia agencies as it relates to laboratory operations.

Multi-site and laboratory responsibilities.

Other responsibilities as delegated by position’s management.

QUALIFICATIONS & SKILLS: Minimum of a Bachelor Science degree in Analytical Chemistry or related scientific degree.

Minimum 3-5 years of relevant work experience in a cGMP environment such as pharmaceutical, biotech, dietary supplement/nutraceutical, food and/or medical device industries.

Minimum 2 years supervisor/leadership experience.

Prefer experience with Regulatory audits.

Experience with analytical instruments such as HPLC/UPLC, GC, LCMS, Raman Spectroscopy and ICP-MS.

Demonstrated expertise in implementation of cGMP requirements.

Strong Method validation skills and in depth understanding of USP/FCC Compendia testing requirements.

Excellent written and verbal communication skills.

Ability to effectively interact with individuals at all levels.

Excellent computer and documentation skills.

Possess strong written and verbal communication skills, as well as interpersonal skills.

Knowledgeable and proficient utilizing a computer, including Microsoft Office.

Possess the ability to creatively solve problems and maintain records.

Excellent organizational skills, accurate recordkeeping and detail orientation is necessary.

Ability to comply with all safety and department regulations.

Physically mobile with reasonable accommodations including ability to lift up to 50 lbs.

Disclaimer This is not necessarily an exhaustive list of all responsibilities, skills, duties, requirements, efforts or working conditions associated with the job.

While this is intended to be an accurate reflection of the current job, management reserves the right to revise the current job or to require that other or different tasks are performed when circumstances change, (e.g.

emergencies, changes in personnel, workload, rush jobs or technical developments).

Equal opportunity employer