Manufacturing Operations Analyst

Position Title: Manufacturing Operations Analyst

Note that this position is NOT a hands-on production position.


The Manufacturing Operations Analyst is part of the Manufacturing Support group and is responsible for writing deviations, conducting investigations and implementing CAPAs. In addition, the Operations Analyst is responsible for production inventory issuance, work order closure, and analyzing technical problems to formulate and develop new or modified solutions to business issues affecting the Manufacturing function.

Essential Duties & Responsibilities
? Write deviations, conduct investigations and implement CAPAs. Track and analyze exceptions and investigations.
? Author and own change control proposals for Manufacturing, driving actions to closure to ensure meeting manufacturing timelines.
? Conduct and document detailed investigations, track exception investigations, change proposals, and audit responses.
? Regularly generate reports in order to analyze actual department performance versus targeted department performance.
? Participate/lead and collaborate with cross functional teams to determine root causes and appropriate corrective and preventive actions related to equipment, process and compliance
? Contribute to the implementation of new equipment, systems and/or procedures and assess impact of new regulatory guidelines on current practices
? Function as Manufacturing Department JDE super user, including performing material transactions in JDE system for manufacturing operations
? Assist with departmental training and auditing
? Responsible for responding to audits, implementing actions and tracking commitments
? Participate in special projects as necessary, such as Operational Excellence programs designed to promote continuous improvement

Qualifications
? Strong knowledge of biologics manufacturing processes and CGMP requirements
? Expertise in Trackwise system (strongly preferred) for deviation, CAPA, and change control management
? Strong problem solving and analytical skills are required.
? Excellent writing ability, particularly documents containing a high level of technical content.
? Ability to communicate effectively with personnel at all levels of the organization and to make technical information understandable to non-technical audiences.
? Ability to produce results with minimal supervision.
? Demonstrated ability to independently drive to solutions and results.
? Must be able to function effectively in a fast-paced environment with multiple high priorities.

Education and/or Experience
Bachelor?s degree in a scientific or engineering discipline (preferred) with 3+ years of manufacturing experience in a CGMP environment. Demonstrated understanding of regulatory, quality and documentation requirements in a CGMP setting.

About Aerotek:

Aerotek, headquartered in Hanover, Md., is a leading provider of technical, professional and industrial staffing services. Established in 1983, Aerotek is an operating company of Allegis Group, the largest provider of staffing services in the U.S. Aerotek operates a network of more than 200 non-franchised offices throughout the U.S., Canada and Europe. For more information, visit .

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