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Quality Assurance Associate

Zolon Tech Solutions Inc. • Jersey City, NJ

Posted 1 month ago

Job Snapshot

Full-Time
Pharmaceutical
QA - Quality Control

Job Description

Title             :  Quality Assurance Associate
Duration   :  6+ Months  
Location    :  Jerseycity, NJ

Job Description:

  • The Associate, Quality Assurance is responsible for supporting Quality Assurance (QA) and Compliance related operational activities with a specific focus on QA documentation (e.g., quality complaints, change control documents, SOP’s, investigations, and other ad hoc cross-category initiatives.
Responsibilities:
  • Reviews product batch records to identify and resolve atypical occurrences.
  • Prepares, reviews and/or maintains a range of other QA documentation as required (e.g., annual product review reports, change control logbooks, training records, quality data binders, directories, databases, etc.).
  • Ensures documents are completed, signed, and date stamped prior to filing or uploading to databases in accordance with MTPA quality systems SOPs.
  • Initiates and assists with reviewing product quality complaints to determine product impact. 
  • Facilitates the closure of complaints in a timely manner.
  • Maintains the complaint data base to prepare and report on metrics for review.
  • Identify trends in Quality Systems and react accordingly to drive positive outcomes.
  • Authors and reviews new and existing SOP’s to further enhance and mature the Quality System.
  • Liaises with service providers, MT Pharma Corporate QA and functional stakeholders on a range of QA activities in particular as it relates to the product quality complaint process.
  • Evaluates and enhances departmental and company and/or vendor site quality procedures to ensure compliance with CGMPs and company policies; communicates any compliance issues to Senior QA Director as they arise.
  • Prepares yearly audit schedule; performs audit preparation activities for supplier, regulatory, and corporate CGMP audits.
  • Prepares, maintains and distributes, as appropriate, monthly reports, quality trend analysis/quality scorecards, trending charts, and meeting minutes.
  • Maintains and keeps track of files, including SOPs, product disposition documents, non-conformance investigations, extension requests, audits and CAPA.
  • Participates on project teams or on-site meetings as directed by QA Director.
  • Performs other duties as required.

Job Requirements

Qualifications:
  • Bachelor’s degree, preferably in chemistry, biology, pharmacy or related scientific discipline
  • Minimum of 2 - 4 years QC/QA experience in a CGMP pharmaceutical environment encompassing change controls, training, complaints, nonconformance investigations, CAPA documents and data management
  • Experience working with service providers and in a matrix organization
  • Experience working with paper and electronic based documentation
  • Experience in preparation of quality score cards and monthly departmental reports
  • Experience in parenteral manufacturing is preferred but not required
  • Understanding of pharmaceutical drug product development and manufacturing
  • Ability to work independently with limited supervision
  • Knowledge of US FDA CGMPs and other regulatory guidance
  • Excellent interpersonal, communication and technical writing skills
  • Proficiency with computer programs such as Excel, Access, PowerPoint, SAP, ISO-Train, Track-Wise or other similar computer databases
  • Physical Demands
  • Lift and pull up to 15 pounds
  • Carry, handle and reach for objects
  • Manual dexterity required to operate office equipment, i.e. computers, phones, copy machine/printer
  • Ability to sit or stand for long periods of time

Thanks & Regards,
Ady James
Zolon Tech 
T: (703)-636-3567 | F: (703) 439-2642  | 
adyjames@zolonls.com | www.zolon.com
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