SEARCH CAREER OPPORTUNITIES

GENERAL SUMMARY OF POSITION:

The QC Analyst III is responsible for conducting routine and non-routine analysis of one or more of the following: environmental monitoring, chemistry/raw materials, in process, and finished formulations according to standard operating procedures.  Compiles data for documentation of test procedures and prepares reports.  Calibrates and maintains lab equipment.  May develop testing methods.  Reviews data obtained for compliance to specifications and reports abnormalities.  Revises and updates standard operating procedures as needed. May perform special projects on analytical and instrument problem solving.  Applies knowledge of good manufacturing practices and good laboratory practices on a daily basis. 

MAJOR RESPONSIBILITIES:

• Supervise the day-to-day operations of assay testing in QC.  Ensure sample collection and testing is executed as scheduled.  Review completed assays for accuracy.  Communicate with management regarding test results.
• Responsible for training and supervising analysts performing QC assays according to SOP and CGMP.
• Oversee the maintenance of lab supplies and reagents and the proper disposal of hazardous material.
• Perform or supervise “special” testing, including assay validations according to SOP or protocol.
• Responsible for generating monthly and annual control logs for all assays performed in the Screening Laboratory.  Analyze control log data for potential assay trends.  Report assay trends abnormalities to the Laboratory Manager.
• Qualify new standard, controls, reagents and materials when necessary.
• Provide technical support for laboratory staff.  Troubleshoot assays as necessary.
• Provide annual retraining to Laboratory staff. Document such training.
• Investigate Laboratory incidents/deviations and write deviation reports.
• May assist in the development of new assay procedures
• Write and revise SOPs as necessary; Perform annual reviews of SOPs.
• Assists in writing validation protocols and final validation reports.
• Analyzes data by statistical and graphical procedures in order to provide pertinent summaries/reports of large volumes of data.
• Prepares written/oral reports for presentation to supervisor or Laboratory staff.
• Performs additional job related duties as required.

REQUIRED QUALIFICATIONS:

• Requires a bachelors degree in Biology or related field with a minimum 5 years of relevant experience or equivalent
• Ability to follow instructions precisely , recognize deviations, and recommend corrective action
• Prior experience in a cGxP regulated environment. Strong working knowledge of cGLP and cGMP regulations.
• Demonstrated ability to train and supervise others
• Ability to conduct complex troubleshooting 
• Computer literate and proficient in MS Word, Excel and other relevant electronic systems
• Strong critical thinking, time management and organizational skills.  Demonstrated ability to multitask and consistently meet deadlines
• 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 (up, down, and laterally) 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, extended work hours to meet business needs