Thermo Fisher Scientific Quality Specialist in Ward Hill, Massachusetts
When you are part of the team at Thermo Fisher Scientific, you will do important work, and you will be valued and recognized for your performance. With talented managers and inspiring coworkers to support you, you will find the resources and opportunities to make significant contributions to the world.
How will you make an impact?
As a Quality Specialist I, you play a key role within the Quality organization ensuring product Certificates of Analysis are developed, verified, and posted for customer reference. Coordinate the collection of supplier documentation, test results, and compliance related data to prepare the Certificate of Analysis (CofA) for each material. Work with Technical Services, Product Management, and Sales departments with customer inquiries.
You will work onsite Monday - Friday, 8 am - 5 pm.
Develop and maintain the product Certificate of Analysis (CofA) library for all Ward Hill products.
For each product received and processed for distribution at Ward Hill, create the CofA using current product specification criteria, supplier provided documentation, and internal testing as applicable. Ensure timely final verification and publishing of the CofA via the Alchemy software.
Interact with internal and external customers to resolve any questions or details related to the product documentation published for reference on the AA/Thermo Fisher Scientific website.
Coordinate activities with international partners in regards to technical documentation requirements for materials provided to our Ward Hill facility for timely distribution and customer shipment.
Serve as Subject Matter Expert (SME) for technical documents (CofA, Certificate of Origin, TSE/BSE, and other product compliance documents) as related to Ward Hill products.
Be the point of contact for any site and global initiatives related to the product technical documentation functions, including template alignment, product specification revisions, and regulatory compliance policy changes.
Serve as site expert with Alchemy data management software and the ERP system maintaining a high level of expertise with software functionality as it relates to routine technical document management at Ward Hill.
Periodically support site investigations, audit observation response, and corrective action completion for issues related to CofA and other technical document related systems in the Trackwise exception management software.
Prepare and maintain site QMS procedures and documents in relation to the CofA and technical documentation process. This includes the ongoing assessment of these documents with site Quality leadership ensuring ISO 9001 review/compliance, and the documents reflect current practice.
Collaborates with Quality and site team members to develop, maintain, and react to metrics for area(s) of responsibility to drive process improvement.
Participate in the internal audit process as host and as Quality participant to fulfill the annual requirements of the site procedure and audit plan.
Perform other duties related to Quality functions as assigned by the Department Manager.
Complies with all global, site, and departmental Quality System procedures and work instructions in accordance with Quality policy and current ISO 9001 requirements.
Supports Thermo Fisher Scientific's commitment for continuous improvement (PPI) by documenting process improvement opportunities throughout the Quality System and PPI process.
Develop and maintain working knowledge of QMS software (i.e. Trackwise, Agile, ERP) completing assignments as necessary to meet site/global metrics' and deliverables.
Participate in internal and external (customer and corporate) audits as necessary to accurately represent the system or area of responsibility.
Environmental, Health & Safety Responsibilities:
Observe all safety rules, procedures, and precautions including requirements for personal protective equipment.
Support Thermo Fisher Scientific's commitment for environmental health & safety per ISO 14001.
Required Skills and Experience:
Bachelor's Degree in Communications, Journalism, Chemistry, or Life Science, or 3+ years of experience with technical documentation in a technical or regulated environment.
Be comfortable working in a customer facing faced-paced, dynamic environment maintaining a strong attention to detail.
Proven ability to drive process improvement through Operational Excellence or PPI tools.
Must have excellent written and oral communication skills and seek opportunities to work collaboratively.
Works independently on behalf of the team and quickly develops criteria to escalate issues for leadership notification and/or support.
Must be computer savvy and have a working knowledge of Microsoft Office, ERP Systems (Oracle/SAP) and be able to quickly learn new software as applied to AA/Thermo Fisher Scientific business systems.
Skills/Experience Valued but not Required:
Technical Writing Certificate or prior experience in technical writing.
Prior completed Chemistry or Life Science coursework.
At least 3 years working in a regulated or GMP environment in a technical, Quality, or compliance related role.
Quality experience in a GMP or regulated chemical or technical environment, primarily with raw material receipt and release role.Ability to identify and create metrics for area of responsibility and highlight trends to elevate issues and opportunities for improvement.
Physical Demands and Work Environment:
- This position may require occasional lifting (up to 20 lbs.)
Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.
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