POSITION SUMMARY
Responsible for performing routine chemical analyses in accordance with established methods, ensuring timely completion of testing to meet required due dates. Conducts method validation for raw materials, intermediates, and finished goods to support quality and compliance standards. Maintains laboratory cleanliness and organization, manages inventory of reagents, standards, and consumables, and contributes to analytical projects and continuous improvement initiatives as assigned.
OTHER ESSENTIAL JOB DUTIES AND RESPONSIBILITIES
· Adapt and optimize compendial and published methods for current laboratory instrumentation and processes.
· Design and execute chemical and physical testing to support product quality improvements and process efficiency.
· Develop, revise, and maintain Standard Operating Procedures (SOPs) and implement new methodologies to ensure product quality and compliance.
· Operate, maintain, and troubleshoot analytical instruments, including HPLC, GC, ICP-MS, and related systems.
· Demonstrate understanding of ISO/IEC 17025 laboratory standards and quality system requirements.
· Support stability program activities, including sample testing and data analysis.
· Investigate and document Out-of-Specification (OOS) results in accordance with regulatory expectations.
· Perform additional duties and responsibilities as assigned to support laboratory operations and business objectives.
WORK ENVIRONMENT
· Work location is in a laboratory setting. Other assignments may be in warehouse or on production floor.
· Duties are performed primarily in a smoke-free environment
Requirements
MINIMUM JOB QUALIFICATIONS AND REQUIREMENTS
· Bachelor of Science in a natural or physical science (Chemistry, Biochemistry, Biology, or Microbiology)
· Proven experience in analytical method development and validation, with strong hands-on expertise in HPLC, GC, ICP-MS, FTIR, UV/Vis spectrophotometry, or comparable laboratory instrumentation.
· Solid background in wet chemistry techniques, including chemical identification, sample preparation/extraction, and titration.
· Experience scheduling and/or performing instrument validation, qualification, and calibration in accordance with laboratory requirements.
· Familiarity Working knowledge of USP and AOAC analytical methods.
· Familiarity with Good Documentation Practices, cGMP and 21 CFR part 111
· Strong written and verbal communication skills, with the ability to effectively interact with cross-functional teams and management.
· Flexibility to work overtime and weekends as business needs require.
PHYSICAL REQUIREMENTS
· Frequently required to stand, walk, bend, kneel, crouch, balance and reach.
· Regularly lift and/or move up to 50 lbs.
Benefits
ProCaps provide :