QC Analyst


Aurora, OH
Employment Type: Temporary to Full Time (Shift: Days)

QC Analyst (Contract Position)
Paris, Kentucky

This position will train on 1st shift and then be assigned to 3rd shift in the future
- 1st shift 7am-3:30
- 3rd shift Sun-Thur 11pm-7am


As a Quality Control Analyst, you will be responsible for testing of raw materials and finished products in our Quality Control laboratory.

PRIMARY RESPONSIBILITIES
  • Conducts routine and non-routine chemistry and microbiological analysis of raw materials, in-process formulations, and final products to established specifications.
  • Utilized and operates laboratory equipment and instruments according to laboratory work instruction or laboratory procedures such as pH, conductivity, UV, KF, FTIR and titrations.
  • Ability to understand and follow Quality Control test methods or compendia methods (USP, EP, BP, JP or ACS) and EXCIPACT standard.
  • Calculates and generates data for compliance to specifications and reports results.
  • Performs technical review of lab data forms such as water, environmental monitoring and direct measure analysis.
  • Calibrates and maintains lab equipment.
  • Enters final results and raw data for tested materials or products in LIMS (Laboratory Information Management System) as needed.
  • May perform investigative analysis to support investigations, complaints or instrument troubleshooting.
  • Performs Environmental Monitoring duties, which requires gowning into cleanroom and collection of air and surface samples while in the cleanrooms.
  • Reviews for discrepancies in data, manufacture COA, COC, and performs data verification in accordance with company procedures.
  • Applies appropriate disposition labels to materials (accepted, rejected, etc.)
  • Handles hazardous materials using all appropriate or mandatory safety PPE and safety equipment.
  • Completes documentation in a legible manner and reviews for accuracy
  • Performs sampling and testing for USP Purified water and Water for Injection
  • Author, review or update lab procedures and Lab instruments Work Instructions.
  • Perform microbiological test such as: bioburden, endotoxin, Dnase, Rnase, Protease, and Phosphatase using proper aseptic techniques.
  • Prepare and properly dispose of microbial media

QUALIFICATIONS
  • Bachelors degree in a science discipline with knowledge and experience in one of the following areas: Chemistry, Biology, or Microbiology
  • 1-3 years of laboratory experience in related field
  • Wet chemistry and microbial testing experience preferred (ex. Acid/Base Titrations, water content, Bioburden, Endotoxin)

KNOWLEDGE SKILLS AND ABILITIES
  • Applied working knowledge of various laboratory instrumentation
  • Ability to work collaboratively in a diverse team environment with people at all levels in the organization
  • Proficiency in Microsoft Word, Power Point, Excel and Access
  • Strong problem solving and analytical skills
  • Ability to communicate effectively, both verbally and in writing

ENVIRONMENTAL WORKING CONDITIONS & PHYSICAL EFFORT
  • Typically works in an office environment with adequate lighting and ventilation and a normal range of temperature and noise level.
  • At times, may be exposed to a variety of different chemicals including flammables, corrosives, oxidizers, and others.
  • Work assignments are diversified. Examples of past precedent are used to resolve work problems. New alternatives may be developed to resolve problems.
  • A frequent volume of work and deadlines impose strain on routine basis.
  • Minimal physical effort is required. Work is mostly sedentary but does require walking, standing, bending, reaching, lifting, or carrying objects that typically weigh less than 10 lbs.

Additional Qualifications

  • QA experience