Senior Associate, QA Document Control
Location: Bristol, PA
- 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.
- 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.
- 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.