QA Associate – Stability Coordinator

16 Elkins, East Brunswick
Posted 2 months ago

Job Summary:

Stability Program is a key quality program managed/maintained and handled within the Quality Assurance department at Avet. Responsibility typically includes review of tasks to look after the entire Stability Management as defined below:

  • Responsible for ensuring that the chambers are properly maintained and monitored on everyday basis.
  • Collect the sample to be charged to the stability chamber and will charge all the samples to stability as required after adequate labeling.
  • Responsible for sample pull as required and submitting for testing.
  • Prepare protocols and reports and circulate for approvals.
  • Maintain the protocols and reports in up-to-date status
  • Responsible for all the necessary activities in SAP that are related to stability protocol, stability results and report falling under stability management function.
  • Required to work in TrackWise Change Control for new or revision in Stability related document and SOP’s
  • Must be able to assess and implementation of Bracketing and Matrixing within Stability Program and willingness to keep updated with applicable Guidances.
  • Assist in other QA related activity as required

    Reporting Relationships    

    •    This position has no direct reports.

    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 3-5 years of experience in the QA department of a pharmaceutical company handling stability and experience managing stability chamber.

  • Knowledge about various Oral Solid Dosage manufacturing activity (dispensing, blending, Granulation, compression, coating, Packaging etc.
    •   Basic knowledge of working on computers – MS Office.

    Key Competencies:

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

    Physical Demands/Factors:

    While performing the duties of this job, the employee is regularly required to mover around the production floor. The employee is regularly required to move around various buildings of Avet. The employee must occasionally lift and or move up to 25 pounds.

    The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

    Avet is proud to be an Equal Opportunity Employer.

    This job description is not all-inclusive. It acts as a guideline and is subject to change over time. Additional duties may be assigned based on business needs.

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Job Features

Job CategoryQuality Assurance

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