Job Description
Duties and Responsibilities:
- Perform various chemical tests such as water analysis, FTIR, ID, HPLC, and other compendial assays.
- Write and perform raw material verification protocols and associated reports.
- Ensure training records are updated and correctly filed to reflect current testing capabilities.
- Perform sampling and labeling of materials as per defined procedures and verify all equipment and instruments.
- Interpret and evaluate data for accuracy, precision, trends, and potential cGMP impact, recommending appropriate corrective actions.
- Ensure all documentation and quality records comply with Good Manufacturing Practices and Good Laboratory Practices and are filed according to existing policies.
- Review and revise Standard Operating Procedures, analytical methods, and related documents to keep them current.
- Conduct analyses on finished products, raw materials, and components, including data entry, review, and approval in a computerized database.
- Contribute to the completion of complex projects, manage time effectively to meet targets, and develop plans for work activities within a team, while exercising judgment with reliance on supervisor and working under their direction.
Education and Experience:
- Applicant must have a bachelor’s degree with 0+ years of experience; OR an associate’s degree with 4 years of experience; OR a high school diploma (or equivalent) and 6 years of relevant experience.
- Experience with laboratory work, particularly using analytical techniques such as HPLC, pH, Polarimetry, etc.
Knowledge, Skills and Abilities:
- Demonstrated technical skills in chemistry laboratory testing.
- Ability to read and understand applicable compendial methods, Standard Operating Procedures, technical procedures, and governmental regulations.
- Knowledge of Good Manufacturing Practices and its application standards, processes, and policies.
- Excellent organizational skills and strong ability to multi-task.
- Strong written and verbal communication skills.
- Proficiency with unique Quality Control instruments to meet accuracy specifications for sample management, retains management, interpretation, and evaluation.
- Proven track record in leading continuous improvement projects
- Strong knowledge of lean manufacturing principles, six sigma methodologies, and statistical analysis
- Strong problem-solving skills and attention to detail
- Ability to manage multiple priorities and meet deadlines.
- Excellent interpersonal skills and the ability to communicate effectively with colleagues at all levels
- Adaptability and willingness to learn new techniques and procedure.
Physical / Mental Requirements:
- Non-existent to minimal travel.
- Must be able to wear appropriate PPE (e.g., lab coat, safety glasses, non-porous shoes, gloves, etc.)
- Ability to lift 30 lbs, stand for 2 to 3 hours at a time, sit for 2 to 3 hours at a time, walk long distances and bend to obtain items from lower shelving/cabinets.
- Intellectual capability to perform complex mathematical problems and perform complex data analysis.
Hard Skills:
- Lab Experience.
- Degree in Life/Phys sciences.
- Analytical.
- Ishihara Test (color).
Interview Process:
- Panel Interview Teams (Camera-on).