Quality Control Sampler

Job Summary

The QC Sampler is responsible for sampling all incoming materials such as raw materials, packaging components, printed material and all other GMP materials using established Standard Operating Procedures (SOPs) and working in accordance with current Good Manufacturing Practices (cGMP).  Collect, sample, and prepare QC Chemical test samples for various analysis laboratories when required.

Area Of Responsibility

• Sample all incoming materials and packaging materials per procedures.
• Inspect all incoming GMP materials per materials specifications Inspect all incoming GMP materials per materials specifications including Identify non-conforming materials cleanliness and defects.
• Follow work-flow procedures from receiving test samples, monitoring inventories, to waste disposal
• Train towards Visual Inspection qualifications
• Accurately sample and weigh Chemical test samples according to Material Specifications and SOP’s using, at times, sterile operating procedures
• Perform QC Release testing for Visual Inspection of cosmetic defects and dimensional inspection of product container closure components
• Initiate product non-conforming reports (UPD) as required (Track Wise) and investigate any problems noted with sampling/inspection process.
• Issue/Dispense and receive labels and packaging materials per production batch record. Keep inventory of all product label/packaging materials
• Enter transactions/transfers into SAP inventory control system
• Maintain records/manual log books per good documentation practices (GDPs)
• Coordinate scrap removal of rejected product
• Update Raw Material Specifications (RMS)/(SOPs) as needed
• Work under general supervision and follows established procedures and instructions
• Operate and maintain the QC Chemical Sampling laboratory to GMP compliance and safety compliance
• Operate, maintain and clean, and calibrate balances
• Maintain laboratory supplies, reagents, chemicals, and equipment inventories for Sampling and Inspection laboratories
• Manage calibration of instruments and equipment used for inspection and perform monthly equipment/ instrument maintenance and cleaning.
• Other duties as assigned

Work Conditions:

Warehouse Environment

Laboratory environment:

• Exposure to noise, bio-hazardous (live cultures), and chemicals
• Exposure to non-hazardous and hazardous chemicals and materials
• Moderate noise, oven heat, open flame, chemical fume hoods areas requiring wearing appropriate safety equipment (i.e. gloves, lab coat, safety glasses and respirator)

Physical Requirements:

• Stand, sit, walk, use hands and fingers to handle or feel, reach with arms and hands, talk or hear, stoop, kneel, crouch or crawl.
• Able to operate basic mechanical tools (i.e.:) calipers, micrometers, and go no-go gages
• Able to drive a fork truck/tow motor/operate forklift
• Close vision; depth perception; ability to adjust focus
• Use of repetitive motion
• Able to operate computer/office machines
• Able to lift and carry up to 50 lbs.

Travel Estimate

Up  to  5 %

Education and Job Qualification

• Minimum of High School/Trade School/Vocational School Diploma, GED, or equivalent.  B.S. degree preferred.
• The requirement for English language proficiency for this job role is Intermediate-B1+ (comparable to Global CEFR Independent B1) level based on the Common European Framework of Reference for Languages (CEFR).
• Good oral and written communication skills and ability to use these skills 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.
• Use of Track Wise software and knowledge of SAP is preferred.
• Use of Lotus Notes software
• Working knowledge of Microsoft Office Applications.
• A self-starter with a hands-on approach and a can-do attitude.

Experience

• Minimum of two (2) years of experience required in a Pharmaceutical/drug (FDA Regulated) industry preferred