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POSITION SUMMARY:

The QC Analyst II is responsible for conducting routine and non-routine analysis of raw materials, in process samples, and finished formulation product according to standard operating procedures.  Compiles data for documentation of test procedures and prepares reports. Calibrates and maintains lab equipment. May develop test methods, review data obtained for compliance to specifications and report results.  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.

ESSENTIAL FUNCTIONS:

• Conducts laboratory testing on raw materials, in-process, bulk and final vial samples as set forth in SOPs
• Performs review and sign-off of assays, adhering to cGMP and cGLP regulations
• Able to works on problems of diverse scope requiring evaluation of situations or data to identify relevant factors
• Performs environmental testing and monitoring
• Maintains reagent, orders supplies and cleans laboratory areas, hoods and common equipment
• Organizes and compiles data and assist in the analysis of data using various procedures
• Generates, maintains and trends assay parameters
• Takes initiative in solving technical problems that arise
• With supervision, troubleshoots assay and instrumental problems within scope of experience
• Participates in writing and revising SOPs, change controls and incident/deviation reports.
• Performs annual review of SOPs.
• 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.
• Ensures labs are clean, safe (in compliance with cGMP) and properly stocked
• Makes detailed observations, analyzes data and interprets results
• Participates in writing technical reports, data summaries or protocols
• Performs other additional job related duties as required

REQUIRED QUALIFICATIONS:

• Bachelors degree in Chemistry or related field
• Minimum of 2-4 years of related experience or equivalent
• Exercises judgment within general practices and policies to select methods and techniques for obtaining solutions
• Able to follow instructions precisely, recognize deviations, and recommend corrective action within scope of training
• Normally receives no instructions on routine work, general instructions on new assignments.
• Attention to detail, and ability to maintain accurate records and excellent proofreading skills
• Excellent written and verbal communication skills to effectively communicate with others
• Able to work effectively both independently and as a member of a team
• Able to work flexible, unusual or extended hours to meet business needs.
• Computer literate and proficient in MS Word, Excel and other relevant electronic systems
• Strong time management and organizational skills
• Able to apply scientific principles to problem solving
• Attention to detail, and able to maintain accurate records with excellent proofreading skills
• Able to communicate effectively with others
• Able to work effectively both independently and as a member of a team
• Able to lift 50 lbs using proper lifting technique
• Ability to work flexible and, at times, extended hours to meet business needs