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QC Analyst I - 2nd Shift (Sunday - Wednesday)
at TOLMAR Inc.
Purpose and Scope
Performs routine testing of raw materials, cleaning samples, bulk intermediate and finished products, and stability samples, according to established regulatory protocols and procedures, in support of manufacturing.
Essential Duties & Responsibilities
Perform physical and wet chemistry testing (pH, viscosity, titrations), including conducting analytical assays of in-process, finished product, stability or raw materials. Complete daily verifications using various analytical instrumentation (HPLC, GC, FTIR).
- Perform analytical testing within assigned timelines.
- Provide peer review of data obtained for compliance in accordance with specifications including cGMPs and report atypical results to supervision.
- Record detailed observations, tabulate, analyze, review, and interpret data from analytical tests using notebooks and various software programs.
- Perform equipment troubleshooting, maintenance and minor repairs.
- Accountable for maintaining an atmosphere of teamwork, cordiality and respect towards co-workers.
- Participates in required annual hazardous waste training. Hazardous waste involvement may include but is not limited to container and tank management and inspections, generation of hazardous waste as a part of production or sampling processes, and transfer of hazardous waste between lab procedure area, satellite accumulation, and storage. Respond to spills per CP 030-0202 Chemical Spill Response.
- Perform additional duties as assigned.
Knowledge, Skills & Abilities
- Basic understanding of government regulated laboratory environment, preferably for drugs and medical devices including GMP, GLP, and ICH and their application to laboratory processes.
- Familiarity in the use of USP, NF and extraction techniques helpful.
- Knowledge of computer systems for sample tracking, laboratory equipment, raw data handling and storage.
- Effective written and oral communication skills.
- Ability to use and maintain analytical laboratory instruments such as HPLC, FTIR, GC, and UV-Vis spectrophotometers.
- Ability to interpret, understand and follow analytical procedures and calculations.
Education & Experience
- Bachelor’s degree in scientific discipline, preferably in Chemistry or Biochemistry.
- Previous experience in an analytical laboratory position preferred.
- Laboratory setting. Will be exposed to solvents, bio-hazardous materials, hazardous waste, and pharmaceuticals.
- Must be adaptable to shifting priorities and operate with a sense of urgency while maintaining high quality in order to meet important timelines in a high throughput lab.
- Business demands may present a need to work extended hours.
- Core hours for this position are from 2:00pm-12:30am Sunday-Wednesday.