Location: Buena, NJ
Reporting Relationships: 1-3
•Assist with method improvements, method validation and method transfer as needed
•Run compliance, testing, and equipment projects as per established timelines
• Ensure data integrity practices in the laboratory meet regulatory and FDA expectations.
•Oversee technical investigations, including hypothesis testing
• Mentoring and training of less experiences team members.
• Analytical chemistry techniques including but not limited to: HPLC, GC, Karl Fisher, Viscosity, Microscopy, pH, specific gravity, IR, and wet chemistry.
• Assist with critical evaluation of testing results.
• Maintain laboratory equipment and instrumentation in good working order, following appropriate procedures for use and clean up.
• Maintain and follow all laboratory systems, cGMPs, safety, and housekeeping requirements.
• Keep supervisor/manager informed of all key quality findings and issues.
• Review of analytical and physical testing data as needed.
• Write and revise routine laboratory SOPs as needed.
• Responsible for maintaining compliance to GMPs in all areas.
• Assume other activities and responsibilities from time to time as needed/directed.
• BS degree in chemistry or a science related field and a minimum of 10 years of experience in Quality Control.
• Demonstrated ability to work on multiple projects and meet timelines
• Knowledge of cGMP requirements. Practical experience with document control, and QA support of manufacturing
• Strong knowledge of Microsoft Word, Excel and Acrobat (PDF) documentation systems.
• Excellent organizational skills.
• Demonstrated ability to work on multiple projects and meet timelines. Detail oriented
• Collaborative working style. Demonstrates professionalism, cooperation and willingness to support team and company priorities in a fast-paced laboratory setting.
• Strong interpersonal skills.
• Good written and oral communication skills.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
• While performing the duties of this job, the employee is regularly required to talk or hear.
• Employee is frequently required to stand for long periods of time; walk; use hands to handle or feel; and reach with hands and arms.
• Employee is occasionally required to sit; climb or balance; and stoop, kneel, crouch or crawl.
• Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.
• The employee must be able to wear all required PPE, including safety glasses, ear plugs, and safety shoes.
This job description is not all-inclusive. It acts as a guideline and is subject to change over time. Additional duties may be assigned based on business needs.