QC Analyst I

Job Summary

Performs various quality control tests on raw materials, in-process and final product using established Standard Operating Procedures (SOPs) and working in accord with current Good Manufacturing Practices (cGMPs)

Area Of Responsibility

• Perform analytical quality control tests and assays for release, stability, and complaint follow-up on raw materials, in-processing and final products following GLPs
• Perform USP test methods and EP test methods
• Perform the quality control tests and assays, and monitor equipment (i.e. water systems, environmental chambers). Maintain records of the data in manual logs following GDPs.
• Wash glassware, prepare reagents, solutions, and equipment for chemical tests and assays
• Send samples to contract laboratories and collect test data
• Use basic lab instruments
• Perform monthly equipment/instrument maintenance and cleaning
• Follow work-flow procedures from receiving test samples, monitoring inventories, to waste disposal
• Train towards Visual Inspection qualifications
• Other duties as assigned
  
  

Work Conditions

• Office
• Lab environment with moderate noise, heat, open flame and radiation in specific areas requiring appropriate safety equipment (i.e. gloves, lab coat, safety glasses and respirator)
• Work with non-hazardous and hazardous chemicals, toxic metals and radioactive materials
• Exposure to or use of syringes and needles
• Requires access/work in chemical fume hoods
• Requires access/work in class 100K, 10K or 100 clean room (mask and boots in conformance with environmental dress codes)
  
  

Physical Requirements

• Stand, walk, sit, use hands and fingers to handle or feel, reach with hands and arms, climb or balance, stoop, kneel, crouch or crawl, hear and talk
• Close vision
• Lift up to 25 lbs.
• Operate computer/office machines
• Ability to wear Personal Protection Equipment
  
  

Travel Estimate

Up to 5%

Education and Job Qualification

• BS in chemistry or related scientific major required
• Good oral and written communication skills
• Ability to follow specific instruction and report assay results (i.e. written SOPs)
• Proficient with wet chemical methods and tests (USP, ACS, Titration, Limit tests, etc.)
• Fundamental knowledge of chemical principles
• Proficient with basic laboratory instrumentation
• Basic computer skills
• Works under general supervision following established procedures
  
  

Experience

• Minimum 0-2 years related experience preferred
• Use of Trackwise software
  
  

The presently-anticipated base compensation pay range for this position is $74,500 to $82,500. Actual base compensation may vary based on a number of factors, including but not limited to geographical location and experience. In addition, this position is part of the Annual Performance Bonus Plan. Employees are eligible to participate in Company employee benefit programs which include medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; and the employee assistance program. Employees also receive various paid time off benefits, including vacation time and sick time.

The compensation and benefits described above are subject to the terms and conditions of any governing plans, policies, practices, agreements, or other materials or documents as in effect from time to time, including but not limited to terms and conditions regarding eligibility. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company, or individual department/team performance, and market factors.