embecta is a global medical device company with a 100-year legacy in insulin delivery and diabetes care. Driven by innovation, purpose, and a commitment to improving lives, we are expanding our portfolio of solutions to serve even more patients, healthcare providers, and communities around the world.

An excellent opportunity for a detail-oriented quality professional with document control experience to manage batch records, drive document revisions, and maintain site documentation systems. You'll work cross-functionally to support compliance, product release, and audit readiness in a highly regulated manufacturing setting.

Responsibilities:

Work with cross-functional teams to support product release.
Perform timely review of batch records and associated documentation to ensure accuracy and compliance with approved procedures.
Track batch record review metrics and support continuous improvement initiatives
Be a key part of the coordination and maintenance of the site’s Documentation System leading document change requests and supporting stakeholders through the document revision process.
Maintain all batch history records and related documentation.
Record and maintain batch record review results in the complaint management system, ensuring quality events are appropriately documented and tracked
Prepare technical documentation including product certification to support worldwide product distribution.
Be a key member of the site audit team, supporting all Regulatory and Customer audits.
Provide support for the Quality Management System as determined necessary by Quality Management.

Educational Requirements and Relevant Experience:

Science/Engineering qualification
A minimum of 2 years experience working in Medical Devices or Pharmaceutical manufacturing environment.
Experience working within an established Quality System
Experience with electronic Quality Management Systems including Batch Control and Document Control ideally with SAP or similar experience.

Knowledge, Skills and Abilities:

Excellent interpersonal and communication skills
The ability to work progressively as part of a team and on own initiative
Eager to learn and follow direction
Excellent attention to detail

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embecta is an Equal Opportunity/Affirmative Action Employer.  We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

Quality Systems Coordinator

Job Description