Job Description

General Summary Description

The QA Specialist I is responsible for assuring the identity, strength, quality, safety and purity of the drugs that are prepared, manufactured, packaged and enforcing compliance with current cGMP practices including raw materials sampling and release, retain sampling and retention, batch record review, and finished product release.

Duties /Responsibilities

  • Performs quality clearance for rooms, equipment, ancillary parts for packaging process & granulation/blending
  • Carries out inspections during the packaging processes, compression/encapsulation process & granulation/blending
  • Performs AQL as required to support the product quality
  • Handles retention samples and logging, as well as upkeep of the room
  • Assist in ensuring production area is always ready to in state of inspection
  • Performs initial batch record review during active processing to identify discrepancy or deviations
  • Notifies management with an discrepancy or deviations, and provides support to the investigation team
  • Provides support in clearance and inspection for compression/encapsulation
  • Provides support in issuance of labeling materials and label control activities
  • Follows, monitors and enforces overall cGMP compliance requirements as specified in SOPs and batch records for weighing, packaging, and in process granulation
  • Assists with new and revised procedures/forms as necessary
  • Ensures that current practices are accurately documented and adequately followed
  • Performs other duties as assigned

Direction Received:           Organize own work with very little direction

Analytical Requirements: Assignments frequently involve decisions based on a wide knowledge of many factors where application of advanced or technical concepts are pedominantly required

Decisions and Judgment:  Recommendations based on the development of facts concerning conformity with a known standard or set policy and procedures

Initiative:                           Problems are of a difficult nature and supervision is limited to assignments and discussion of problems

Minimum Qualifications

Bachelor’s Degree in Science, Chemistry, Engineering or related field and 1-2 years experience in pharmaceutical, biotech industry or equivalent combination of education and experience required. Master’s Degree preferred.

Application Instructions

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