1001 Durham Ave South Plainfield, NJ 07080 | 908.941.5456

PuraCap
QA Technician

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 POSITION DESCRIPTION

 

Position Title: QA Technician Date Prepared: August 23, 2017
Reports To: Quality Manager Department: Quality

 

Position Summary:

A quality assurance technician familiarize themselves with policies and procedures, especially all aspects of the quality system.  They enter a work area, inspect work and observe operations. They then report on any noncompliance with written instructions and policies.  They work with and report any issues and concerns to the Quality Manager.

Essential Duties and Responsibilities:

  • Responsible to enforce company’s QA compliance to all cGMP standards and procedures
  • Must provide prompt response to Operations’ requests for support
  • Perform Receiving/Inspection on incoming drug products and components, including completion of required forms and gathering of required documentation
  • Conduct thorough inspections in the Primary and Secondary Packaging areas to grant line-clearance and complete required cleaning logs
  • Perform line setup inspection
  • Perform first and last-piece checks to ascertain compliance to customer specifications as-shown on the bills of material and document these checks on the required form(s)
  • Conduct thorough in-process checks at intervals prescribed
  • Complete QA release of finished product, following Operations release
  • Monitor radio traffic and whenever possible respond to needs to which other QA Technicians or the Printed Component Area cannot
  • Provide back-up to Printed Component Area when necessary, which includes:
    • Count received label rolls 100% to establish an accurate quantity
    • Pull and stage labels and printed components for upcoming batch records, such that Operations is not delayed during a changeover
    • Maintain inventory of printed components through the use of sheets that log all outgoing and incoming transactions
    • Print and stage shipping labels for upcoming batch-record or lot changes, as well as shipping labels for partial shippers at the conclusion of each run

 

Qualifications/Requirements: 

 

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.  The requirements listed below are representative of the knowledge, skill, and/or ability required.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

  • Must be very detail oriented
  • Good oral and written communication skills
  • Ability to follow directions, good listening skills
  • Work in fast paced environment, must be able to multi-task
  • Posses the ability to comprehend the requirements of written policies, procedures and instructions
  • Familiar with cGMPs preferred

 

Education/Training/Experience:

 

Requires a high school diploma or equivalent

 

 

PuraCap Pharmaceutical LLC is an equal opportunity employer and affords equal opportunity to all applicants and employees for all positions without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other status protected under local, state, or federal laws.

 

If interested in applying for any of the above positions at PuraCap, please send your Resume / CV to humanresources@puracap.com