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SalaryAs a member of the Quality Control Information Systems at New England Biolabs (NEB), this individual is primarily responsible for drafting and approving quality documents STM, SOP protocols and reports. In addition to drafting documents this individual will be responsible for Benchling System design and improvement for Quality group as well as continues training and guidance for production groups. Additionally, this individual will support OEM/custom specification generation and revision. Furthermore, additional responsibilities include salesforce customer support. This position is based at our Ipswich, MA location.
Primary Responsibilities:
- Execute and Optimize Quality Systems (ex. Benchling, SAP, Ebase)
- Organizing, reporting and trending results.
- Draft Quality documentation SOPs, test methods, protocols and reports.
- Initiate and participate in laboratory out of specifications (OOS) investigations and determine CAPA plans.
- Execute system qualifications and train staff on systems.
- Collaborate with tech transfer team(s) for the transfer of new products from a system perspective.
- Maintain an up-to-date training file for the Quality Department.
- Collaborate/lead inter and intra departmentally in systems development, optimization, implementation and qualification.
Required Qualifications and Experience:
- B.S. degree in biology or related field.
- Minimum 10 years’ experience working in a Quality setting.
- Have a strong knowledge of ISO 13485 and ISO 9001 Quality Management Standards and/or GXP concepts.
- Possess strong recordkeeping skills and the ability to analyze, trend, interpret and report results to senior staff.
- Have strong interpersonal skills and the ability to effectively collaborate with customers and internal colleagues.
- Have a working knowledge of MS Office applications, SAP and ELN/LIMS systems.
EEO Statement
New England Biolabs is committed to fostering a diverse and inclusive community; as an EEO/AA employer, New England Biolabs considers applicants for employment without regard to, and does not discriminate on the basis of, race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status or disability. More in-depth details of EEO are available
here.
Information regarding New England Biolabs commitment to Diversity, Equity and Inclusion can be found
here.
New England Biolabs is a participating employer in the Employment Verification (
E-Verify
) program.If you need an accommodation for any part of the employment process because of a medical condition or disability, please send an email to
hr@neb.com
or call 978-927-5054 to let us know the nature of your request.
