Quality Control Analyst I
GENERAL SUMMARY OF POSITION:
The QC Analyst I – Chemistry is responsible for conducting routine and non-routine analysis of raw materials, in process, and finished formulations according to standard operating procedures. Reviews data obtained for compliance to specifications and reports abnormalities. May perform special projects on analytical and instrument problem solving. Applies knowledge of current Good Manufacturing Practices and Good Laboratory Practices on a daily basis.Responsibilities
- Conducts chemical testing on raw materials, in-process, bulk and final vial samples as set forth in SOPs, adhering to cGMP and cGLP regulations.
- Performs preliminary review and sign-off of assays.
- Performs environmental testing and monitoring as required.
- Performs temperature monitoring of incubators, cold rooms, and freezers.
- Prepares and tests reagents used in assays as needed.
- Organizes and compiles data and assists in the analysis of data by statistical procedures
- Generates, maintains and trends assay parameter data for designated assays.
- Takes initiative in solving technical problems that arise. Troubleshoots assays and instruments problems with Laboratory Supervisor.
- Participates in writing and revising SOPs, change controls and incident/deviation reports.
- Assists in the development and optimization of testing methods.
- Assists in the qualification of new controls, standards and reagents.
- Maintains log books related to inventory and equipment.
- Ensure labs are clean and safe (in compliance with cGMP), and properly stocked.
- Makes detailed observations, analyzes data and interprets results. Prepares technical reports, data summaries or protocols.
- Performs other additional job related duties as required
- Bachelor’s degree in Chemistry or related field with a minimum 0-2 years of relevant experience or equivalent
- Ability to follow instructions precisely , recognize deviations, and recommend corrective action within scope of training
- Ability to adapt to a cGLP and cGMP regulated environment
- Ability to troubleshoot within scope of training
- Computer literate and proficient in MS Word, Excel and other relevant electronic systems.
- Strong time management and organizational skills. Demonstrated ability to multitask and consistently meet deadlines
- Ability to apply scientific principles to problem solving
- Possesses well developed attention to detail, ability to maintain accurate records and excellent proofreading skills
- Excellent written and verbal communication skills. Ability to communicate effectively with others
- Demonstrated initiative through past experience
- Ability to work effectively both independently and as a member of a team
- Requires ability to work flexible and at times, unusual or extended hours to meet business needs.
Requires ability to lift 50 lbs using proper lifting technique