Quality Control Contractor

Job Description

Duties and Responsibilities:

• Conducts analytical and functional testing of raw materials, intermediates, and/or finished goods kits according to approved SOPs.
• Perform testing using chemistry clinical analyzers and document test results accurately using SOPs and electronic workbooks.
• Document test results, complete batch records, and perform lab investigations using relevant information and processes under cGMPs.
• Summarize and evaluate test data, maintain lot histories, and evaluate data for trends and excursions according to established SOPs.
• Performs other responsibilities to support the needs of the department as assigned by Supervisor.

Education:

• Minimum BS/BA in Chemistry, Biochemistry, or Bioscience.
• Note: Demonstrated ability and/or additional experience may be considered in lieu of a BS/BA degree.

Experience:

• 0-2 yrs Quality Assurance/Quality Control experience, preferably in the medical diagnostics industry.

Knowledge, Skills, and Abilities:

• Strong laboratory skills including pipetting, safety, handing of Biohazardous material, and hazardous chemical handling.
• Understanding of cGMP and how it applies to the work environment.
• High level of reading comprehension skills.
• Ability to follow written and verbal directions with a high level of accuracy.
• Must be able to write clear, understandable documentation.
• High level of verbal communication skills.
• Intermediate word processing and spreadsheet software skills.
• Ability to manage multiple tasks simultaneously.
• Ability to work independently.
• Ability to perform simple data analysis and to summarize results.
• Basic math skills including calculation of concentrations and dilutions and a strong grasp of algebraic concepts.

Physical Requirements / Work Environment:

Controlled Substance Handling:

• This role involves the handling, management, and oversight of controlled substances.
• The role will be responsible for ensuring compliance with all relevant regulations and guidelines on controlled substances.

Exposure to Controlled Substances:

• The role may be exposed to controlled substances during their duties.
• Proper safety protocols and protective measures will be provided and must be strictly followed.

Safety Protocols:

• Ability to adhere to strict safety protocols and procedures to ensure a safe working environment.

Background Check:

• Successful completion of a background check, including screening for any history related to controlled substances.