Our client is a leading provider committed to women’s healthcare and medical services and is excited to share they are looking for a new Analytical Scientist to join their growing team! This is a great opportunity for a professional analytical chemist with 3-5 years of experience in the medical device, pharmaceutical, or biotech industries.

As an Analytical Scientist, you will be responsible for performing analytical tests to support production and research & development. You will assist in managing the QA Analytical Chemistry Laboratory with their equipment & supplies and participate in projects related to analytical chemistry within product development.

Schedule: 1^st Shift: Monday-Friday, 8am-5pm (with flexibility to work 9am-6pm)
Direct Hire

Responsibilities:

• 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.

Education/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.

Physical Requirements

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

**This job description is a complete list of all desired skills but not all are required.  We strongly encourage candidates who have some of the skills to apply.  We look forward to a conversation to learn more about you**

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