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Senior Associate, QA Document Control

Abzena Philadelphia ,PA
  • Posted: over a month ago
  • Full-Time
  • Benefits: 401k, dental, life_insurance, medical, vision
Job Description

 

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.
Company Description
About Abzena

Abzena is a life sciences group with its headquarters in the UK and two sites in the US. Abzena offers a range of complementary services and technologies for the selection, development and manufacture of biopharmaceuticals, products based on antibodies or other proteins.

Working with companies and academic groups all over the world, including most of the top 20 biopharmaceutical companies, Abzena supports the development and manufacture of better treatments for patients. Eleven antibodies which have been created using Abzena's technologies (ABZENA inside products) are currently being progressed through clinical development by our licensees. More information on our ABZENA inside products is available here.

Abzena was created through the incorporation of Antitope, PacificGMP, PolyTherics, The Chemistry Research Solution (TCRS) and Warwick Effect Polymers, all of which now trade as Abzena.

Abzena

Why Work Here?

If you are looking for a dynamic environment where you can grow and excel your career, then Abzena is the place for you!

About Abzena Abzena is a life sciences group with its headquarters in the UK and two sites in the US. Abzena offers a range of complementary services and technologies for the selection, development and manufacture of biopharmaceuticals, products based on antibodies or other proteins. Working with companies and academic groups all over the world, including most of the top 20 biopharmaceutical companies, Abzena supports the development and manufacture of better treatments for patients. Eleven antibodies which have been created using Abzena's technologies (ABZENA inside products) are currently being progressed through clinical development by our licensees. More information on our ABZENA inside products is available here. Abzena was created through the incorporation of Antitope, PacificGMP, PolyTherics, The Chemistry Research Solution (TCRS) and Warwick Effect Polymers, all of which now trade as Abzena.

Address

360 George Patterson Blvd
Philadelphia, PA
USA

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