Quality Compliance Specialist


Lexington, Massachusetts

2 months ago

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Quality Compliance Specialist
Lexington, Massachusetts

2 months ago

Job Description

Job Title: Quality Compliance Specialist
Duration: 6 months
Location: Lexington, MA 02421

Primary Duties:
  • Primary duties of the position are focused around non-laboratory support of the QC functions.
  • Primary activities would generally include but not limited to analytical method transfer, analytical method validation, data analysis, data trending, project and testing coordination product and material specification management, inspection support, document authoring, revisions, initiating/completing quality systems, method/equipment validation and method projects activities.
  • Works under general supervision. Work is reviewed for soundness of judgment and overall adequacy and accuracy.
  • Contributes to the completion of organizational projects and goals. Errors in judgment or failure to achieve results would normally require a moderate expenditure of resources to rectify.
Specific QC Focus Areas:
  • Technical Services: Area is focused on data analysis, data trending, project and testing coordination product specification management, LIMS interface, CoA generation (including interaction with the IT systems such as LIMS that enables electronic management of this activity), and inspection support.
  • Stability: Area is focused on data analysis and trending of stability data, data reporting, coordination and planning of stability studies, involvement on quality events requiring stability input.
  • Technical Support: Area is focused on various technical projects in support of the GMP laboratories, such as automation support, method projects activities (ex. method transfer and validation support activities, method monitoring), critical reagents and reference standard programs.
  • Raw Materials:  Area is focused on various projects in support of the Raw Materials department. Support includes (but not limited to) material specification creation/revision, document creation/revisions, initiating/completing quality systems, method/equipment validation and implementing operational excellence initiatives.
Responsibilities: Job Function and Description
  • 50-60% data analysis, data trending, project and testing coordination, support of product specification management, COA generation, material specification creation, document revisions.
  • 20-30% Regulatory and/or inspection support, method projects activities, initiating/completing quality systems.
  • 20% Involvement in other QC activities as required (ex. records retention)
Education and Experience Requirements
  • Experience in Analytical Method Transfer, Analytical Method Validation, HPLC, Bioassays, CE assays, compendial verification, biologics
  • Requires a bachelor’s degree and a minimum of 5 years of related experience
Additional Specific Experience:
  • Excellent communication, interpersonal and organizational skills. Ability to work well both independently and in a team environment. Ability to prioritize work and multitask.
  • Conducts work in compliance with cGMPs, safety and regulatory requirements.
Key Skills, Abilities, and Competencies
Knowledge: Frequent use and general knowledge of industry practices, techniques, and standards. General application of concepts, and principles. Position requires critical thinking.
Key Skills: MS Office, LIMS, SAP, Trackwise, EDMS, compliance and strong science understanding

About Us: Established in 2004, SPECTRAFORCE® is one of the largest and fastest-growing diversity-owned staffing firms in the US. The growth of our company is a direct result of our global client service delivery model that is powered by our state-of-the-art A.I. proprietary talent acquisition platform, robust ISO 9001:2015/ISO 27001 certified processes, and strong and passionate client engaged teams. We have built our business by providing talent and project-based solutions, including Contingent, Permanent, and Statement of Work (SOW) services to over 140 clients in the US, Canada, Puerto Rico, Costa Rica, and India. Key industries that we service include Technology, Financial Services, Life Sciences, Healthcare, Telecom, Retail, Utilities and Transportation. SPECTRAFORCE is built on a concept of “human connection,” defined by our branding attitude of NEWJOBPHORIA®, which is the excitement of bringing joy and freedom to the work lifestyle so our people and clients can reach their highest potential. Learn more at: http://www.spectraforce.com
Benefits: SPECTRAFORCE offers ACA compliant health benefits as well as dental, vision, accident, critical illness, voluntary life, and hospital indemnity insurances to eligible employees. Additional benefits offered to eligible employees include commuter benefits, 401K plan with matching, and a referral bonus program. SPECTRAFORCE provides unpaid leave as well as paid sick leave when required by law.

Equal Opportunity Employer: SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at LOA@spectraforce.com if you require reasonable accommodation. 
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $56.00/hr.

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