Demo

Quality Compliance Associate

Accupac
Lakewood, NJ Full Time
POSTED ON 2/17/2025
AVAILABLE BEFORE 5/5/2025

Job Description

Job Description

Basic Job Functions :

Ensure company-wide adherence to cGMP standards, Standard Operating Procedures, and customer specifications.

Essential Functions of the Job :

  • Support the Annual Drug Product Review (ADPR) process.
  • Support the Deviation and Change Control process.
  • Support the CAPA process including initiation, closure and performance of Effectiveness Checks.
  • Complete Supplier Incident Reports and follow up with vendors.
  • Support site cGMP trainings as needed.
  • Update packaging batch records and issue batch records for use.
  • Work in the Trackwise System.
  • Revise and write SOPs as needed.
  • Route documents in document management system.
  • Update spreadsheets and maintain departmental metrics.
  • Perform other duties as assigned.

Minimum Requirements of the Job :

  • Comply with all company policies, SOP’s, current Good Manufacturing Practices and other relevant regulatory requirements.
  • Maintain training at or above 90% of assigned curriculum.
  • Possess knowledge of Good Documentation Practices.
  • Possess a working knowledge of MS Office applications (word, excel, etc...)
  • Attention to detail.
  • Ability to work individually and in groups.
  • Interpersonal skills.
  • Ability to perform basic math skills.
  • Ability to read, write and understand English.
  • Effective communication skills.
  • Meet deadlines as assigned.
  • Physical Requirements :

  • Walking within the confines of the facility.
  • Supervisory Responsibilities : No

    Travel : None

    Education and / or Experience : The Quality Compliance Associate I must have a college degree and 0-2 years of Quality Control / Assurance experience in related field and LIMS experience. The Quality Compliance Associate II must have a college degree, 2 plus years of Quality Control / Assurance experience in a related field and LIMS experience.

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