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
- Perform job functions in a safe manner consistent with site safe practices and regulatory (e.g. - OSHA) requirements
- Participate in weekly/monthly safety training, identify potential safety hazards and cooperate with investigations of safety related incidents
- 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
- Maintain required level of training needed to perform a GMP task
- Productivity
- Perform routine sample analysis requiring general laboratory skills such as weighing, pipetting, titration, and basic operation of laboratory instrumentation
- Comprehend and follow approved test methods accurately in the performance of sample analysis to ensure adherence to "Right-the First Time" philosophy
- Perform analysis with a practical understanding of the test procedure and instrument operation
- Use available software to control instrumentation, collect data, process and calculate results, and report results
- Perform testing to evaluate physical characteristics of raw materials and finished products
- Work under direction provided by supervisor
- Calculate results and assess conformance with specifications
- Notify manager immediately of nonconforming data or unexpected occurrences
- Organize work schedule to complete assigned tasks efficiently and on schedule
- Maintain accurate record of analysis and perform documentation to company standards
- Prepare test solutions, reagents, and samples used in analysis
- Other duties as assigned
QUALIFICATIONS
- BS in Chemistry, Biochemistry, Microbiology or Biology or related discipline
- 0-3 years experience in a pharmaceutical QC laboratory environment
- Understanding of cGXP requirements preferred
- Organization, communication and interpersonal skills
GMP DECISION-MAKING AUTHORITY
Responsible for decisions related to:
- When laboratory management must be notified to determine whether an investigation is warranted
- Maintain required level of training needed to perform a GMP task
- 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."