Analytical Scientist

Position Summary

Responsible for performing analytical chemistry tests in support of production and research and development.  Manage QA Analytical Chemistry Laboratory with regard to equipment and supplies. Participate in product development projects as it relates to analytical chemistry. Lead failure investigation for OOS investigations.

Specific Job Functions

• Organize and maintain laboratory area(s) including equipment parts and consumable supplies in accordance with GMP regulations.
• Initiate, track, and perform routine instrument maintenance, calibrations, and performance troubleshooting, with appropriate documentation in the Quality System.
• Support manufacturing, research and development, and quality assurance in the production, monitoring, and release of medical device products; i.e. set up apparatus for chemical reactions, prepare compounds, monitor commercial production and collect and analyze samples produced and standards by Gas Chromatograph/ HPLC/ titration/ etc.
• Analyze and review data generated prior to submitting the data to the next level of review, including performing routine data calculations.
• Manage OOS/ OOT process in order to identify causes of test failures and detect test result trends.
• Adhere to analytical procedures, quality control protocols, and GMP documentation processes as required by specific methodologies.
• Assist R&D in test method development for QA/ QC related analytical tests.
• Assist with chemical safety program through the management of chemical inventory and Safety Data Sheets.
• Manage test method validation process, leading the efforts to maintain test method validation.
• Assist with process validation activities through protocol and report review/ approval.
• Lead analytical method development activities.
• Support quality assurance activities by performing internal audits, quality inspections, and other quality functions as determined by management.

Physical Requirements

• Good vision
• Good manual dexterity
• Ability to lift over 25 lbs.

Minimum Qualifications, Education & Work Experience

• B.S. in Chemistry or related field.
• Three (5) years’ experience in medical device, pharmaceutical or biotech industry working in Good Manufacturing Practices (GMP) laboratories.
• Must have a strong technical knowledge and experience in the use of GC, HPLC, titrations, pipetting and dilutions, etc.
• Must have a strong technical knowledge and experience in equipment care, maintenance, and troubleshooting performance of GC and HPLC equipment and parts.
• Must be detail oriented.
• Must have a demonstrated ability to effectively and clearly communicate concepts, ideas and knowledge to other individuals and teams; both written and oral.
• Strong project leadership skills.
• Proficiency in MS Word and MS Excel.