MINIMUM QUALIFICATIONS:

• Bachelor’s degree in Life/Physical sciences with 0+ years of experience (open to fresh grads) OR;
• Associate’s degree in Life/Physical sciences with a minimum of 4+ years of experience OR;
• High school diploma or GED with a minimum of 6 years of relevant experience
• Demonstrated technical skills in chemistry laboratory testing
• Proficiency with unique Quality Control instruments to meet accuracy specifications for sample management, retains management, interpretation, and evaluation
• Experience with Ishihara Test (color)
• 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 multitask
• Strong written and verbal communication skills

PREFERRED QUALIFICATIONS:

• Experience with laboratory work, particularly using analytical techniques such as HPLC, pH, Polarimetry, etc.
• 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 procedures

• 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 a supervisor and working under their direction
• Perform tasks associated with maintaining Good Manufacturing Practices (cGMP) compliant Quality Control and Stability laboratories
• Support environmental monitoring/water testing in the QC Raw Materials Laboratory
• Test incoming raw materials per compendial methods
• Follow Environment Health and Safety requirements for site and QC laboratories
• Support product transfers, new product development, regulatory queries, cost improvement projects, and Drug Product plant support for Cleaning Validation
• Operate within established HR policies and basic colleague relations guidelines.
• Write Standard Operating Procedures (SOPs), technical reports, project plans, etc.