Perform Quality Assurance tasks such as sampling, inspections, and tests designed to ensure manufactured products are in compliance with internal SOP’s, Safety initiatives, Company policies, FDA and DEA regulations.  Document all work performed, ensuring accuracy and thoroughness.  Inform management of any deviations from established standards/procedures.

• Inspect and approve rooms, lines and equipment prior to use by manufacturing and R&D personnel.
• Approve components for in-process operations.
• Monitor manufacturing areas for compliance with internal SOPs, cGMPS and FDA/DEA regulations.
• Document all work activity in appropriate batch records, forms, and logs to ensure accuracy and compliance.
• Sample in-process items, and finished products. Perform required inspections and testing of in-process items and finished products.  Process and distribute samples to different departments.
• Review records for cGMP compliance for accuracy and thoroughness.
• Inform management of problems, failures and deviations from established internal and regulatory standards.
• Help / assist in training of QA Inspector I level team members.
• Apply disposition stickers to components and in-process materials.
• Issue QA Alerts whenever any questionable component, in-process material or product is identified at any stage of production or storage.
• Perform swab and Rodac Plate sampling as required.
• Perform transactions in JD Edwards when required.
• Review tasks within Master Control and Trackwise

Competencies:

Education / Experience:

High school diploma or equivalent.  Minimum of three years of professional experience in similar position; demonstrated ability to perform required duties.  Knowledge of internal SOPs, cGMPs, FDA/DEA regulations. Basic computer skills required.  Basic math skills required (i.e., calculating %, addition, subtraction, multiplication, division).  Ability to read, write, communicate and follow instructions (verbal and written) in English is required.  Familiarity with sampling methodologies (i.e. AQL, ANSI-stds) required.  ASQ certification a plus.

Judgment / Decision Making:

Duties performed within a framework of departmental or functional protocol requiring a moderate degree of original thinking.  Makes routine recommendations.

Work Environment:

Majority of time spent at Manufacturing plants with exposure to machines with moving parts airborne products, chemicals, muscular strain and noise.  Carelessness could result in minor injury.  May handle or work with laminates and units containing a Class II Controlled Substance.

Ability to work second and third shift, if required.  Ability to work Saturday and/or Sunday, if required. 

Physical Demands:         

Regularly required to stand for more than one hour at a time; occasionally lifts and carries objects weighing up to 50 pounds.  Visual acuity and manual dexterity required to proofread documents and operate computer.