What are the responsibilities and job description for the Laboratory Supervisor position at Formulated Solutions?
THE COMPANY:
Formulated Solutions is redefining the Pharmaceutical and Self-Directed Consumer Healthcare CDMO experience through creativity and invention; delivering our world class Marketing Partners unmatched formulations, innovative packaging and cost effective, reliable supply.
Formulated Solutions is and shall always be a company of people with the knowledge and dedication to provide our Marketing Partners with a single source solution for delivering quality and innovative products to market. We shall embrace changes and new opportunities as a vehicle to continually develop and grow sustainable relationships. As a company we shall never accept anything less than a culture that fosters creativity, growth, and profitability for both our Partners and the company.
PRIMARY PURPOSE:
The Laboratory Supervisor is responsible for overseeing daily operations, staff, and projects to ensure compliance and efficiency. Key responsibilities include supervising and training lab personnel, ensuring quality control and regulatory adherence, managing workflow and scheduling, and handling administrative duties and budgets. The role requires a strong background in chemistry, often with experience in analytical techniques and specific pharmaceutical industry practices.
MAJOR DUTIES AND RESPONSIBILITIES:
- Perform microbiological testing in support of environmental testing, raw materials, in-process, final product, stability, and method validation.
- Oversee daily operation of QC Laboratory, including all microbiological and analytical activities.
- Accurately records raw data and analyzes data, as well as calculates and interprets the results. Provide excellent aseptic and microorganism identification techniques.
- Order supplies ensuring that the microbiology laboratory is adequately supplied.
- Plan daily technical activities in order to meet established timelines. Provide input to establish project timelines.
- Qualify, calibrate, and maintain laboratory equipment.
- Perform general laboratory maintenance.
- Peer review data and reports.
- Write, review, and revise SOP’s as required.
- Ensure testing is performed accurately and in compliance with GLP, GMP, USP, SOP and other approved test methods
- Proactively investigate and identify areas of improvement.
- Investigate, support, validate and implement new laboratory procedures and techniques.
- Maintain a level of technical knowledge and understanding of microbiological and Analytical testing consistent with current scientific literature.
- Perform scientific literature searches and evaluations.
- Design, within a defined scope, experiments or a series of experiments to address specific project goals.
- Train laboratory personnel in microbiological techniques as required.
- Responsible for Cleaning Validation and Method Validation activities.
- Follow cGMP, cGLP and OSHA guidelines with regards to work practices and safety.
- Other duties, which may be assigned from time to time, by the Executive Management of the company.
- Proficiency in laboratory techniques and equipment is essential, with experience in specific methods like HPLC, GC, or LCMS being a significant plus. Knowledge of data integrity principles is also important.
EDUCATION & JOB REQUIREMENTS:
- A minimum of a BS in Microbiology, Chemistry or related field, Masters preferred
- Minimum of 5 years’ experience preferably in the pharmaceutical industry
- Capable of preparing cGMP and other laboratory documents
- Excellent knowledge of computer systems and software
- Good knowledge of cGMP and FDA regulations
- Excellent interpersonal, organizational, communication skills
WORK ENVIRONMENT:
- GMP Manufacturing and Laboratory Environment
- May be exposed to laboratory chemicals and solvents