Analytical/ Quality Control Chemist
- $45,000 to $65,000 Yearly
- Vision , Medical , Dental
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.
Primary responsibilities of this role include the following:
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
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
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
MONARCH PCM LLCFort Worth, TX
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