QA Manager - Full-time / Part-time

Summary:
We are actively seeking a candidate to manage our Quality Assurance (QA) systems team in Woburn, MA. The ideal candidate is one who thrives working in a highly dynamic, team- oriented environment sharing the common goal of providing our clients with the information they need to improve the safety and effectiveness of materials produced and used in pharmaceutical, biologics and medical device products.
The QA Manager is directly responsible for management of all day-to-day QA administration and consulting support. This includes all document control, GLP oversight, data package preparation, administrative tasks, document approvals, report approvals, performance of internal audits, data auditing, consulting with internal clients to provide guidance and direction, as well as other tasks identified in SOPs. The Woburn QA Manager collaborates with the Oakdale, MN Senior Director of QA and staff on a routine basis to accomplish harmonization.The ideal candidate is self-guided and highly motivated, demonstrating a strong sense of initiative, desire to collaborate with all departments and an interest in continuing to acquire new knowledge and skills.

Job Responsibilities:
* Manage the Document Control system in Woburn with support from Oakdale, MN to include review of documents, approval of change requests and archive of documents.
* Provide QA Review and Approval of Excursion/non-conformances, deviations, OOT, OOS, and CAPA Reports. May need to author some records and investigations.
* Review and Approve Method Transfer, Validation and Project Requirements Protocols and Reports
* Serve as Quality representative on all applicable client projects
* Oversee all site GLP activities
* Review and approve GLP Protocols and Reports
* QA Consulting with Internal Clients
* Manage training records
* Conduct annual GLP and as applicable GMP training
* Oversee Data Package Preparation Process
* Data Review Supervision and Data Auditing
* Perform Internal Audits and GLP phase inspection audits
* Collaborate with Oakdale staff including remote meetings and internal audits
* Assist with Review and Approval of Quality Agreements with Suppliers, Service Providers and Subcontractors
* Review and Approve Supplier, Service Provider and Subcontractor Surveys
* Assist with completion of Client Paper Audits
* Host Client On-site Audits and prepare Responses
* Review and Approve Equipment Records including basic laboratory equipment calibration, maintenance, and events such as storage units, balances, pipettes, and pH meters.
* Travel to the other sites as well as subcontractors to conduct audits (approximately 1 trip per year)

About Aerotek:

Our people are everything. As a Best of Staffing® Client and Talent leader, Aerotek® Inc. has distinguished itself as a leader in recruiting and staffing services, by having a deep understanding of the intersection of talent and business. As a strategic partner to more than 17,000 clients and 300,000 contract employees every year, Aerotek's people-focused approach yields competitive advantages for its clients and rewarding careers for its contract employees. Headquartered in Hanover, Md., Aerotek operates a network of over 230 non-franchised offices with more than 6,000 internal employees dedicated to serving our customers. Aerotek is an operating company of Allegis Group, a global talent solutions provider. To learn more, visit .

Aerotek is acting as an Employment Agency in relation to this vacancy.