Location: Glen Rock,PA, USA
Job Summary:
The Quality Assurance (QA) Specialist is responsible for QA Product Release functions including batch record review and generation of certification reports for products shipped from the Glen Rock site. Role ensures product shipments are dispositioned in a timely manner based on internal procedures and external customer/regulatory requirements. Other responsibilities include the administration of the Document Control and Training software system (Veeva) as well as management of current DMFs on file.
Essential Functions:
Responsible for QA Product Release for all shipments to customers.
Reviews internal batch records to general good documentation practices and ensure compliance to internal and external requireme
nts.Generates and reviews product quality certification documents that are sent to custom
ers.Ensures all product is dispositioned appropriately prior to shipme
nt. Initiates nonconformances for compliance issues observed during the batch record review proc
ess.Able to communicate with manufacturing, customer service, planning, quality control and process engineering in resolving batch record iss
ues.Elevates significant/critical Quality issues to Managem
ent.Responsible for filing and maintaining batch records and product release documentation as required.
Responsible for review and approval of documents in the Document Control system (Veeva Quality Docs)
Reviews all documents in the workflow for general formatting and internal procedural requirem
ents. Trains/assists associates on the proper use of the Document Control System including any continuous improvement ef
forts.Assists in any upgrades/validation activities related to the Document Control System.
Responsible for administering the company's Training system (Veeva Vault Training)
Acts as Training Administrator to ensure appropriate training is assigned to relevant controlled doc
uments. Assists Human Resource Department with the maintenance of user roles in the system by ensuring Learner Roles, Curricula, and Training Requirements are assigned approp
riately.Assists in upgrade/validation activities related to the system as required.
Additional Responsibilities:
Performs internal audits as assigned and participates in others as required.Provides support for external audits (Customer and Third Party) as required.Generates, reviews, and reports metrics as required.Responsible for administration of Drug Master Files through annual electronic submissions.Proficient in the use of the current electronic quality management system (TrackWise) to ensure all material impacted by Quality issues is dispositioned appropriately. Ability to read technical documents and reports and identify errors and potential noncompliance issues based on learned process knowledge.
Job Specifications:
Requires an Associate's or Bachelor's in Biology/Chemistry or technical discipline plus a minimum of one year relevant experience or five years related experience in regulated industry (i.e. chemical, medical device, pharmaceutical, etc.)Experience working in an ISO 9001 or ISO 13485 regulated environment preferred.Excellent interpersonal and communication skillsProficient in Microsoft Office (i.e. Outlook, Excel, and Word) as they relate to daily functions.Experience with TrackWise, Veeva, Oracle ERP, or other similar operating systems preferred.