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Senior Specialist - QA Document Control

Company: ProClinical
Location: Philadelphia
Posted on: May 28, 2023

Job Description:

Proclinical is seeking a Senior Specialist - QA Document Control for a leading biotech company located in Philadelphia, PA. This position is responsible for supporting the Quality Document Control program and ensuring compliance to quality objectives and regulatory requirements. In addition, this position will be responsible for providing training and guidance to users on Electronic Document Management System (EDMS).Must be eligible to work in the US.Job Responsibilities:

  • Manage and monitor the processing, review, and approval of revision-controlled documents in the Electronic Document Management System (eDMS) with minimal supervision.
  • Ensure compliance with controlled document format and content.
  • Maintain master documents and records (both hardcopy and electronic) to ensure documentation is retrievable and files are accurate, complete, and well organized.
  • Manage the document periodic review process.
  • Issuance of batch records, forms, logbooks, validation documents, labels, and other controlled documents as required.
  • Provide user assistance and training on the eDMS.
  • Provide continuous feedback on improvement of the Document Control program!
  • Responsible for ensuring documents are retained per record retention policies and procedures.
  • Attend meetings and escalate issues/concerns to QA Management.
  • Assist with generating Quality Assurance Document Control metrics.
  • Provide support for internal and regulatory audits and inspections.
  • Adheres to Good Manufacturing Practices (GMP) and Standard Operating Procedures (SOPs), including Good Documentation Practices.Skills and Requirements:
    • Bachelor's degree in Life Sciences discipline preferred
    • Minimum of five (5) years of experience in QA Document Control in pharmaceutical or biopharmaceutical GMP based facility. Experience in other areas of Quality (Quality Operations and/or Quality Systems) is a plus.
    • Proficient with document change management and FDA quality systems.
    • Proficient in an eDMS (specifically MasterControl). Experience as MasterControl System Administrator or MasterControl Document Control Administrator is a plus.
    • Proficient in document formatting
    • Must possess a high level of attention to detail and proficient in Word and Excel.
    • Strong computer, organizational, and compliance skills
    • Ability to work effectively on multiple projects simultaneously with minimum supervision.
    • Strong interpersonal and communication skills.If you are having difficulty in applying or if you have any questions, please contact Miranda Gilmer at (+1) 570-277-7065 or is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.Proclinical Staffing is an equal opportunity employer.#LI-MG2INDCQA

Keywords: ProClinical, Philadelphia , Senior Specialist - QA Document Control, Other , Philadelphia, Pennsylvania

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