The Quality Control Chemist performs daily analytical functions within the Quality Control department including but not limited to raw material control, product evaluation, analytical assays, validation implementation and analysis, microbial analysis, and special projects.
- Perform routine evaluation, analysis, and release of raw materials, in-process bulk product, and finished goods with minimal supervision via instrumental and wet chemical analyses.
- Perform laboratory batch adjustments for nonconforming in-process bulk product, including batch calculation and documentation from Lab Batch to Production scale.
- Responsible for documentation control related to evaluation, analysis, and release of raw materials, bulk product, and finished goods.
- Responsible for formula change control including submission to Document Control to change Master Formula when needed.
- Coordinate and maintain internal control of standards, retains, samples, and documentation as required.
- Responsible for daily sampling and analysis of DI Water.
- Perform, coordinate, and oversee sampling, analysis, and documentation for process and equipment validation.
- Conduct routine microbiology control programs within plant environment.
- Review and interprets analytical and microbiological test results; follows through with non-conforming results.
- Implement and/or coordinate vendor validation program per standard operating procedures.
- Responsible for preparing samples and documentation submissions to customers and outside test laboratories. Distributes responses as appropriate.
- Communicate with suppliers and/or contractors on evaluation issues concerning raw materials, customer supplied bulk product, and instrument maintenance.
- Participate in internal cGMP and regulatory compliance audits as necessary.
- Bachelors of Science (BS) in chemistry, microbiology, chemical engineering or related field from a four-year college or university.
- Ability to read and interpret documents such as safety data sheets, safety rules, operating and maintenance instructions, and procedure manuals and test methods.
- Must be able to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, percent, and calculate dilution factors.
- Must be able to follow verbal and written instruction and communicate clearly and concisely both written and verbal.
- Ability to collaborate, communicate, and negotiate with others in an effective and professional manner.
- Ability to meet deadlines in a fast-paced environment.
- Strong attention to detail.
While performing the duties of this job, the employee is regularly required to use hands to finger handle or feel. The employee is occasionally required to stand, walk, sit, reach with hands and arms, stoop, kneel, crouch, or crawl, and taste or smell. The employee must occasionally lift and/or move up to 40 pounds. Specific vision abilities required by this job include close vision, color vision, peripheral vision, depth perception, and ability to adjust focus.
Compensation is commensurate with level of knowledge, education, skills, and experience applicable to the position.
We understand that each team member’s situation is unique, and so it is our intent to offer an overall benefits package that can be shaped and molded by each individual to fit their family’s needs. Our current benefits package, which is available to all full-time team members, includes medical, dental, vision insurance, 401k retirement plan, flexible spending accounts, life and disability coverage, and other voluntary benefits.
We want everyone to feel welcome, respected and we are committed to providing the best space, experience and workplace for our teams – no matter what race, color, religion, sex, sexual orientation, gender identify, national origin, veteran or disability status and all the other fascinating characteristics that make us different.