Quality Assurance Compliance Specialist IV

Company: Apex Life Sciences ( Learn More )

General Information
US-CT-New Haven
Not Specified
Not Specified
Not Specified
Job Description

Apex Life Sciences is looking for a QA Specialist IV for one of Our Clients


  • The QA Specialist IV will assist in daily activities for the ongoing development and operations of the GMP and GLP Archive with Quality Assurance.In support of Document Control, the candidate will take the lead in carrying out the operational requirements that result from policies, procedures, regulations, and guidances governing the management of records that exist in print and electronic form.
  • This role will help manage record retention schedules, outreach to other internal/external archival support staff, and the acquisition of GMP/GLP Archive records. Record control will be maintained at many levels, such as original hardcopies, electronic files, and physical security.
  • The QA Specialist IV will coordinate documents such as laboratory notebooks, binders, procedures, photographs, computer printouts, protocols, technical reports, resumes, audits, facility records, validation documents, and certificates of analysis.
  • The QA Specialist IV will contribute to the completion of milestones associated with specific projects and supports quality systems related to document reviews, training, change control, deviations, corrective actions/preventative actions, and investigations.
  • Expedient retrieval of organized and complete records for internal requests, agency requests, and regulatory inspections is a key element to this position.
  • Equally important is the ability to review documents for compliance to regulations, guidances, and internal procedures/policies.
  • This position will provide the incumbent the unique opportunity to lead in various areas of GMP/GLP Quality Systems. 

  • 9+ Years of Experience Skills Qualifications -Minimum of 7 years GMP related experience in biopharmaceutical / pharmaceutical or related industry.
  • Experience in developing, implementing, and evaluating archives or records management processes and systems. This includes cataloging, filing, and retrieving of records.
  • Experience with GMP/GLP global regulatory requirements.
  • Experience with electronic systems (e.g.FirstDocs and TrackWise) and databases. Capable of moving, copying and recovering large numbers of files and folders in a Windows environment.
  • Knowledge of the creation and management of records retention schedules
  • Knowledge of archival metadata and metadata management
  • Ability to work in a fast-paced environment -Performs a variety of tasks Competencies -Convey information effectively through excellent written and verbal communication skills.
  • Ability to exercise judgment with defined procedures and practices to determine appropriate action.
  • Ability to prioritize daily activities in order to meet internal and external customer needs for established timelines in a fast-paced environment.
  • Ability to monitor and report on assigned tasks, goals, and objectives.
  • Identify problems and review related information to develop options and implement solutions. -Ability to arrange items or actions in a certain order or pattern according to a specific rule or set of rules (e.g., patterns of numbers, letters, words, pictures, operations).
  • Understand the challenges and opportunities in developing processes for effective capture, preservation, and management of paper and electronic records.
  • Demonstrate high quality work that is detail oriented.
  • Focus on customer service. English (Speak, Read, Write)
  • If you are interested in position please email your resume to [Click Here to Email Your Resumé] for immediate consideration. 

    Job Requirements