SUMMARY OF POSITION

The Quality Control Chemist I / Microbiologist I:

• Performs routine testing to assess the conformance of raw materials, finished products, and/or stability samples to predetermined product specifications.
• Performs routine testing in conformance with approved procedures, accurately and concisely documents data, and reports results.
• Demonstrates a basic knowledge of SOP's and GMP regulations as related to the pharmaceutical quality control laboratory.

ORGANIZATION STRUCTURE

The Quality Control Chemist I / Microbiologist I reports into the Manager Quality Control or Team Leader Quality Control.

RESPONSIBILITIES

Primary responsibilities of this role include the following:

• Safety
  1. Perform job functions in a safe manner consistent with site safe practices and regulatory (e.g. - OSHA) requirements
  2. Participate in weekly/monthly safety training, identify potential safety hazards and cooperate with investigations of safety related incidents
• Compliance
  1. Conduct assigned tasks in compliance with cGXP requirements, current industry standards, compendia standards, FDA expectations and internal procedures
  2. Assist with laboratory investigations to ensure they are conducted in a timely manner and are completed within established target completion dates
  3. Maintain required level of training needed to perform a GMP task
• Productivity
  1. Perform routine sample analysis requiring general laboratory skills such as weighing, pipetting, titration, and basic operation of laboratory instrumentation
  2. Comprehend and follow approved test methods accurately in the performance of sample analysis to ensure adherence to "Right-the First Time" philosophy
  3. Perform analysis with a practical understanding of the test procedure and instrument operation
  4. Use available software to control instrumentation, collect data, process and calculate results, and report results
  5. Perform testing to evaluate physical characteristics of raw materials and finished products
  6. Work under direction provided by supervisor
  7. Calculate results and assess conformance with specifications
  8. Notify manager immediately of nonconforming data or unexpected occurrences
  9. Organize work schedule to complete assigned tasks efficiently and on schedule
  10. Maintain accurate record of analysis and perform documentation to company standards
  11. Prepare test solutions, reagents, and samples used in analysis
  12. Other duties as assigned

QUALIFICATIONS

1. BS in Chemistry, Biochemistry, Microbiology or Biology or related discipline
2. 0-3 years experience in a pharmaceutical QC laboratory environment
3. Understanding of cGXP requirements preferred
4. Organization, communication and interpersonal skills

GMP DECISION-MAKING AUTHORITY

Responsible for decisions related to:

1. When laboratory management must be notified to determine whether an investigation is warranted
2. Maintain required level of training needed to perform a GMP task
3. Suitability of analytical equipment/instruments for use

EOE/M/F/Vet/Disability

This role will offer a base salary that is commensurate with experience and demonstrated skills in the $50,000-$53,000 range plus Overtime

"An Equal Opportunity Employer, including disability/vets."