Senior Associate, QA Document Control - Abzena

Senior Associate, QA Document Control

Location: Bristol, PA
Area: Quality

Current Responsibilities:

  • Assists and coordinates reviewing, processing, and maintaining company’s Document Control system through:
    • Organization, maintenance, and archival of controlled documents.
    • Writing, reviewing/revising, approving, and processing Standard Operating Procedure (SOP), Batch Record, Protocol, and equivalent documents through the Document Control system.
    • Issuance of document, part, lot, and investigation numbers.
    • Issuance and review of electronic and paper-based GMP logbooks.
  • Assists with continually evaluating Quality Systems and procedures while independently identifying areas for improvement and assisting in the implementation of new practices.
  • Assists with reviewing, processing, and maintaining the training program.
  • Assist with internal and external audits.
  • Assists with customer communication and customer audit processes.
  • Writes, reviews, and approves discrepancy reports (e.g. deviations, CAPAs, complaints, etc.).
  • Assists with executing and maintaining Electronic Management Systems as it relates to Quality.
  • Issue and review labels used for GMP processes.
  • Assists with generating and providing Quality metrics for review.
  • Performs other related duties as assigned.

 

General Responsibilities:

  • Operates to the highest ethical and moral standards.
  • Complies with Abzena’s policies and procedures.
  • Adheres to quality standards set by regulations and Abzena’s policies, procedures and mission.
  • Communicates effectively with supervisors and colleagues.
  • Ability to participate effectively as a team player in all aspects of Abzena’s business.
  • Travels as needed to attend audits, professional conferences, and training opportunities.
  • Responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company’s policies and practices.

 

Qualifications/Skills Required:

  • BS/BA degree in a relevant life sciences discipline or equivalent is preferred.
  • Minimum of three (3) to five (5) years’ experience in a GMP oriented environment and Quality Assurance.
  • Knowledge of GMP regulations, good documentation practices, cGMP, 21CFR, USP and other applicable regulations, standards and guidance.
  • Experience with implementing and maintaining a document control program is preferred.
  • Knowledge of industry standards and regulation requirements for biologics and paternal products in clinical development.
  • Ability to analyze with proficiency in the application of problem solving and root cause analysis methodologies.
  • Skill in writing to effectively communicate complex ideas and concepts.
  • Detail oriented with strong analytical, written, and verbal communication skills.
  • Must be familiar with Microsoft Office applications.
  • Ability to work well under pressure, independently, multi-task, be organized and have good communication skills.
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