Sr. QA Specialist (Change Control & Documentation)

Job Summary Description: The Sr. QA Specialist (QACC&D) is responsible for the development, control, and issuance of Master Batch Records (MBR) for the Newark site. These documents are cGMP critical and subject to FDA inspection. Responsible for processing MBR related Change Requests (CRs) and supporting the timely implementation of CR Action Plans.

In addition to the above, the incumbent provides multidiscipline quality assurance and regulatory compliance support. The incumbent works under minimal supervision supplying support to the Change Control process by providing a uniform and consistent methodology for controlling both planned and emergency changes to GMP-impacted processes, equipment, utilities, and materials. The Sr. QA Specialist ensures program compliance with cGMPs, worldwide regulatory requirements, AstraZeneca standards, and customer expectations.

Major Responsibilities
Coordinates the development, maintenance, and implementation of Master Manufacturing and Packaging Batch Records (MBRs) for all product/packages. Review all electronic mock-ups for accuracy in order to ensure all changes included are authorized by approved CRs.

Responsible for tracking and evaluating the proposed and approved Production batch record changes to determine implementation scenarios and proper timing via numerous MySAP and DDS functions and reports.

Analyzes open CRs for Master Batch Records to determine which changes to bundle into new revisions and subsequent revisions. Ensure bundling of changes does not impact areas of the MBR that should not be changed.

Under minimal direction and supervision, process MBR related CRs

Evaluate and bundle submitted MBR related CRs and ensure scope of change is properly documented and the products and documents tagged as affected fit with the intent of the change.

Circulate the CR for formal draft review and approval.

Resolve CR comments and/or conflicts.

Respond and address technical questions and/or issues.

Provides Operations with timely updated revisions per production schedules.

Ensures that the CR process and MBR system complies with Good Manufacturing Practice regulations and other FDA Regulations, as well as internal AstraZeneca policies.

Serves as department representative for any projects relating to MBR documentation changes/upgrades, process improvements, new product and or line introductions.

Develops and executes MBR related functional test scripts in TDMS.

Maintains comprehensive product master files and a chronological record of MBR changes for each product/package.

Responsible for maintaining MBR related SOP?s to reflect current practices.

Manage MBR CR close out process.


Provide support to the Site Change Control program ensuring compliance with cGMP, regulatory, and AstraZeneca requirements.

Function as a Site contact for Change Control. Assist in the initial technical review and circulation of proposed Change Requests. Assist in the development of Action Plans for proposed Change Requests.

Ensure Newark CRs are processed in a timely manner to meet project timelines, production timelines, and customer expectations.

Provide support for the daily operation of the Change Control program:
- Ensure that accurate change control documentation is completed for the Site.
- Review work orders performed on GMP equipment to confirm compliance with Change Control program.

Track status of open/overdue items.

Provide support for the key users from across the site on the Change Request process, promoting a thorough understanding of the program among all Site departments.

Establish excellent working relationships with functional areas and ensure that the expectations of Site customers are met.

Effectively use strategic influencing skills while negotiating at various levels within the organization to ensure issues are appropriately resolved.

Participate on project teams and support the Change Control requirements associated with major Site projects and new product introductions.

Support departmental special projects and initiatives.


Responsibilities

Bachelors Degree in relevant life science or Engineering discipline.

5+ years in Quality Assurance, Manufacturing/Packaging Operations, Supply Chain, or Technical Services.

Demonstrated knowledge of Operation processes.

Excellent communications skills.

A comprehensive knowledge of GMPs.

Knowledge of PC environment, computer networks, hardware, word-processing and Excel.

Preferred Background
Technical Document Management and AZ Change Management Experience.

Knowledge of MySAP.