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QA Associate - 2nd Shift

Posted about 1 month ago

  • Sector: Scientific
  • Contact: Michael Menzer
  • Contact Email:
  • Contact Phone: (732) 353-4231
  • Start Date: 2021-07-12
  • Job Ref: 21-11785
Essential Functions:

01.Determine whether quality activities and related results comply with cGMP requirements.
02.Perform and monitor all production floor QA related functions for Soft-gel Manufacturing process.

03.Perform and monitor all production floor QA related functions for manufacturing process for solid dosage (tablets and hard gelatin capsules) and drug product in powder form.

04.All the QA related functions required must be performed and carried out as per established company standard and procedures and assure that manufacturing/production is according to cGMP regulation.
05.The typical tasks/activity performed as the production floor QA are listed here but not limited to such as:
Logbook maintenance on daily and calendar basis
Providing required approval for production activity and make appropriate entries in respective batch manufacturing records/MMR.
Verify raw material and components prior to usage as required and checking and monitor the dispensing/weighing process.
Check cleanliness and provide usage approval of equipment and production rooms in production department namely granulation, Tableting, Encapsulation, Coating, Soft-gel and Packaging.
Collect granulation, tablet, capsule, soft-gel and packaging samples at various stages of production.
Perform and collect in-process samples e.g. for individual blend sample for uniformity, and composite samples and submit it for QC testing.
Perform drying curve sampling and verification of moisture by Ohaus Moisture analyzer.
Perform Hardness, AQL DT Friability and Thickness testing of tablets
From QA perspective participate and monitor IQ-OQ-and PQ and Preventive maintenance of production equipment.
Process validation, process characterization, cleaning validation and time limit validation monitoring
Provide approvals for setup of machines and commencement of production.
Assist packaging operation whenever required.

Specialized Skills and Knowledge:

Minimum Associate degree with Chemistry as a major subject alternatively minimum 3 years of experience in working as a floor QA for a pharmaceutical company
Knowledge about various Oral Solid Dosage manufacturing activity (dispensing, blending, Granulation, compression, coating, Packaging etc.
Knowledge of In-process testing like Hardness testing, Thickness testing, Disintegration testing, Friability testing etc. including the knowledge of related instruments.
Basic knowledge of working on computers MS Office.

Key Competencies:

1. Analytical Skills
2. Problem Identification and Solving Skills
3. Communication Skills in English