Title:  Laboratory Supervisor, QC Chemistry

Date:  Jun 24, 2022
Location:  Sun - Billerica - Plant
Company:  Sun Pharmaceutical Industries, Inc (USA)

Job Summary

Supervise the Quality Control Laboratory activities, ensuring compliance is maintained with cGMP, ISO, GLPs and company policies and procedures.  The supervisor will also be responsible for GMP testing of raw materials, in-process and finished products, stability samples, and non-routine sample analyses per established procedures and methodology.

 

Area Of Responsibility

  • Execute and review analytical quality control release, stability and complaint (follow-up) testing for raw materials, in-process and final products to ensure compliance with cGMPs, GLPs, GDPs, ISO Quality Assurance Procedures, SOPs and established deadlines
  • Maintain a comprehensive QC training program for analytical personnel and reinforce the training with appropriate assignment(s) and delegation of responsibility
  • Monitor and prepare formal evaluations of employee performance to ensure continued compliance
  • Ensure safe operations in the laboratory
  • Perform internal lab audits
  • Work with the Manager to coordinate transfer of methods (new/alternate, customer supplied (ILQ) or improved methods) or technology (instruments ) into the QC laboratory
  • Research, develop, validate and train QC analysts on new/improved instruments and test methods
  • Identify, procure, install and qualify required QC instrumentation/equipment.  Develop, author, and execute instrument IQ/OQ and PQ protocols
  • Assist with validation programs (Empower reports, spreadsheets, etc.)
  • Maintain laboratory programs to monitor and evaluate systems or equipment (i.e. analytical instrument/equipment, etc.) status, ensure efficient laboratory performance and compliance with preventive maintenance, qualification, and calibration schedules.  Oversee and maintain major laboratory programs (e.g. instrument requalification program, reference standard program).
  • Maintain laboratory programs to process, monitor and evaluate the status of test (release, complaint, or investigation) samples in the Quality Control Laboratory to ensure efficient laboratory throughput and to help maintain monthly metrics
  • In conjunction with the Manager, oversee and allocate personnel required to ensure deadlines are met
  • Troubleshoots assays as needed
  • Provide mentoring and training to analysts on laboratory tests, skills, and lab processes
  • Spectrophotometers—Balances, infrared (IR), gamma radiation and RCP assays, Flame atomic absorption (AA), ultraviolet/visible light (UV/VIS), polarograph, high pressure liquid chromatography (HPLC), total organic carbon analyzer, conductivity meter, Polarograph, pH meter, Autotitrator, Karl Fischer moisture analyzers, high temperature furnaces and oven, fume hoods, stirrer/hot plates, propane burners, compressed gas regulators and cylinders, melting Point, Osmometer, Gas Chromatography (GC), Particle size analyzer
  • 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
  • Controlled area/clean room
  • Exposure to noise, heat, open flame and radiation in certain areas
  • Exposure to non-hazardous and hazardous chemicals, toxic metals (arsenic, lead, and mercury)
  • Cryogenic gases (LN 2) and radioactive materials
  • Requires access/work in chemical fume hoods
  • Exposure to/use of syringes and needles

 

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 and color vision
  • Must wear personal safety equipment (gloves, lab coat, gowning, safety glasses & respirator)
  • Lift up to 25 lbs.

 

Travel Estimate

Up to 5%

Education and Job Qualification

  • B.S.in chemistry or related scientific major required
  • Computer literacy/proficiency; PC with spreadsheet and or instrument control software
  • Comprehensive knowledge of wet chemical and instrumental analysis methods, including method development and validation

Experience

  • Minimum 6-8 years related experience with minimum 2 years related experience  as a laboratory supervisory preferred
  • Proficient verbal, written and interpersonal communication skills
  • Excellent mentoring, training, and oversight skills
  • Ability to work with minimal supervision
  • Strong chemistry theory skills
  • Strong organization skills
  • Position requires a balance between administrative (office) duties and laboratory work
  • Understanding of cGMP, GLPs and ISO requirements
  • Use of Trackwise, Novatech, and Empower software preferred