Analytical/ Quality Control Chemist

Performs routine and complex sample analysis requiring refined laboratory skills, technical expertise, and astute observation to assess the conformance of raw materials, finished products, and/or stability samples to predetermined product specifications.

Performs testing with expertise and understanding of scientific principles in conformance with approved procedures, accurately and concisely documents data, and reports results.

Demonstrates an advanced knowledge of SOP’s and GMP regulations as related to the pharmaceutical quality control laboratory.

RESPONSIBILITIES

Primary responsibilities of this role include the following:

Compliance

Conduct assigned tasks in compliance with cGXP requirements, current industry standards, compendia standards, FDA expectations and internal procedures

Assist with laboratory investigations to ensure they are conducted in a timely manner and are completed within established target completion dates

Ensure they have been appropriately trained before performing a GMP task

Schedule and/or perform necessary validation, qualification and calibration of laboratory equipment/instruments as needed

Productivity

Perform routine and complex sample analysis requiring refined laboratory skills and technical expertise such as HPLC, GC, Dissolution, USP/EP raw material testing, wet chemistry, spectrophotometric techniques, or microbiological techniques

Comprehend scientific principles and follow approved test methods accurately in the performance of sample analysis to ensure adherence to “Right-the-First Time” philosophy

Applies theoretical knowledge, education, experience, and training in conjunction with technical resources to troubleshoot and resolve problems

Use advanced software functions to control instrumentation, collect data, process and calculate results, and report results

Uses available resources to effect system improvement or development of laboratory systems

Communicate with clients, contractors, and regulatory agents as required

Provide leadership and guidance to junior staff and coordination of work efforts for junior staff in relation to project work assigned

Work independently and seek supervision when required

Calculate results and interpret data in relation to project objectives and historical data

Notify manager immediately of nonconforming data or unexpected occurrences and proactively participates in resulting investigation

Organize work schedule and coordinates with other analysts to complete assigned tasks efficiently and on schedule

Update various GMP documents including but not limited to SOP’s, change controls, safe practices, protocols, templates and reports demonstrating strong technical writing skills

Perform specialized maintenance and calibration of laboratory equipment (Metrology) as needed

Perform required daily maintenance and/or calibration of laboratory equipment/instruments consistent with established SOP’s as needed

Familiar with department and plant systems and effectively operate within systems to achieve desired results

Witness analytical notebooks of peers

Other duties as assigned

QUALIFICATIONS

 BS degree in Chemistry, Biochemistry, Biology or Microbiology or related discipline

At least 2 years’ experience in a pharmaceutical or related environment

Strong organization, communication and interpersonal skills

Oral and written communication skills including technical writing