QA Associate

Job ID 17-00290

Industry Pharma

Job Type Permanent

Location Denville, NJ

Job Title Department/Division Date Written
QA Associate Quality Assurance/RA 11-1-16
  Managers Title FLSA Status
 Denville, NJ Director of QA Exempt
Position Purpose or Objective
The QA Associate primary responsibilities are……………………………………………………….
Major Areas of Responsibility
  • Verification of Instruments and equipment DQ, IQ, OQ, PQ; Calibrations
  • Verification of USP and other pharmacopeia monographs; DMF
  • Verification of dispensing of active ingredient; audits of staged batch materials in pre-weigh area, blending/manufacturing/coating; manufacturing equipment cleanliness
  • Review and approval of Protocols and Reports: Stability, Process Validation, Bulk Hold Study, Calibrations, Shipping study, Freeze Thaw Study, Photo stability
  • Verification of calibration tags on balances, equipment and instruments
  • Review, approval, and logs: Change Controls: Investigations of Deviations, Incidents, and OOS & OOT
  • Review and approval of analytical raw data and release COA's
  • Review and approval of analytical method validation protocol, reports and analytical raw data
  • Ensure qualifications, calibration and routine maintenance of stability chambers
  • Tracking of monograph changes
  • Review and approval of STP's and Specifications
  • Acts as a Stability Coordinator
  • Maintenance of retain, RLD and Bio-waiver study samples
  • Approval and release of pilot, pivotal and commercial batches
  • Review and approval of batch manufacturing and packaging records
  • Charge, maintain and withdraw stability study samples
  • Sampling of APIs, finished products (including stability) and in-process samples
  • Training of new employees and maintenance of Training records
  • Complaints & ADR: receipt, logging, investigations and submissions in collaboration with Regulatory team
  • Organizing the documentation room by sorting all protocols, reports and raw data into appropriate project boxes, allocating space for all documents, including training files, laboratory notebooks and GMP raw data
  • Overall cGMP compliance
  • Any other work assigned by the reporting division/management

Required Knowledge, Skills and Abilities
  • Must be able to communicate effectively whether in person, on the telephone, or through correspondence.
  • Ability to enter data accurately. 
  • Ability to handle multiple tasks well. 
  • Ability to facilitate resolution of client issues
  • Must have advanced skills in Microsoft applications
  • Excellent interpersonal skills and ability to establish and maintain effective working relationships with both internal and external stakeholders
  • Experience developing and creating formal presentations; advanced presentation skills, intermediate computer skills
  • Excellent verbal and written communication skills
  • Self-directed
Education and Experience
  • BA or BS required degree preferred
  • At least 3 years of -----required, preferred in the pharmaceutical industry
Physical Demands
  • This position requires the employee to routinely use a computer and telephone.