QC Chemist-3rd Shift

QC Chemist-3rd Shift

Scope:

The QC Chemist is responsible for the evaluation and testing of all incoming raw materials, in-process bulk, finished bulk and packaged products in accordance with all applicable standard operating procedures (SOP) and work instructions (WI).

Primary Responsibilities/Accountabilities:

• Inspects, samples and tests all incoming raw materials from tanker delivery,and bulk chemical tanks, and RO water, in botha lab and warehouse environment.Manages results to ensure specifications are met according to company and customer requirements.

• Prepares Certificate of Analysis (CofA) for product test results and completes product releases in the SAP system.

• Conducts testing and standardization in-process bulk, finished bulk, and packaged products; and with preparing necessary reagents and equipment (such GC, HPLC, FTIR) required to complete the quality control analysis.

• Assists QC management with investigations of Out of Specification (OOS) results, which may require retesting and/or resampling product.

• Reviews bulk product testing results to ensure any required adjustments to the bulk are within specification, and submits recommended adjustments and corrective measures to the QC management team.

• Maintains customer standards and requirements for chemicals and finished goods.

• Provides recommendations to improve lab operations and assists with writing or updating departmental SOPs and WIs.

• Maintains appropriate records associated with OOS or non-conformance results for bulk product and finished goods.

• Assembles and calibrates scientific testing and laboratory instruments.

• Performs all work in a manner that is consistent with the company's quality system and FDA good manufacturing practices, includes maintaining a clean, contaminant-free and orderly work area at all times.

• Follows, promotes and enforces KDC's safety and environmental policies, practices and procedures.

• Performs other duties as assigned.

Education & Experience:

• BS in Chemistry, related science field, or equivalent quality/lab experience.

• Strong experience using various laboratory equipment and aseptic sampling techniques.

• SAP experience, desired.

• Manufacturing experience desired.

Knowledge, Skills & Abilities:

• Strong problem solving, analytical and technical skills.

• Good attention to detail.

• Self-starter with strong work ethic and positive attitude.

• Strong communication (both written and oral), interpersonal, team building and organizational skills.

• Ability to perform multiple tasks simultaneously and manage time efficiently and effectively.

• Strong computer skills (Microsoft Office).

• Good understanding of FDA Good Manufacturing Practices Regulations (GMP's) and OSHA safety requirements.

• Ability to operate various scientific laboratory equipment and aseptic sampling.

• Ability to understand and complete procedure documents in accordance with SOPs and WIs.

• Ability to perform professional, scientific laboratory work to ensure conformity to company and customer requirements.

• Knowledge of Safety Data Sheets and related safety precautions.

Minimum Requirements:

• Must be 18 years or older.

• Able to work overtime & weekends as required.

• Wear hairnet, safety glasses, long pants, steel toe shoes/boots and any other uniform standards.

• Read, comprehend and follow written and verbal instructions.

• Sit, bend, stoop, climb, and stand for long periods of time in one place.

• Lift items up to 50lbs

• Exposure to a variety of cleaners and sanitizers, hot water and chemicals.