Senior Quality Compliance Specialist


Lexington, Massachusetts

12 days ago

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Job Description

Job Title: Senior Quality Compliance Specialist
Location: Lexington, MA, 02421 (Hybrid Role)
Duration: 06 Months

Actual Job Title: Biologics & Plasma Complaint Lead

Recommended experience: 0-3 years for Associate level, 4-7 years Intermediate level, and 8+ for Senior level hires
Responsibilities Quality Compliance Specialist works closely and collaboratively with the Product Quality Management Leads and across Technical Operations and other functions / stakeholders across the Business to execute product quality surveillance strategies including but not limited to Product Quality Complaint administration, investigation and reporting, Product Quality Review / Annual Product Review (APQR), Product Recall, Incident Management, and support for the integration of new product acquisitions into post marketing surveillance.
Responsibilities: Post Marketing Product Quality Surveillance:
Provide support to delivery, drive and maintain effective Product Quality Surveillance systems including but not limited to:
o Effective global Product Annual / Periodic Product Quality Review
o Preparation as per applicable SOP
o Supports Global System for Product Quality Reviews/Annual Product Review
o Coordinate APQR Review meetings
o Create and Track APQR elements. Follow-up on pending items and facilitate discussions to resolve outstanding items
o Responsible for maintaining a schedule for APR/PQR; responsible for obtaining and compiling required data from various internal and external suppliers, manufacturers and packagers of our Product.
o Review SOP periodically for compliance.
o Provide QA input on compliance issues concerning Product Quality Reviews.
Acquisition & Integration & Project Support:
Support and facilitate delivery of products entering the in-line supply chain into Quality Systems, including but not limited to; APQR, Product Compliant System, and Product Management and monitoring programs such as Critical Process Verification and monitoring
Support and participate in Quality and cross-functional project teams. Regulatory Awareness, Inspection support and Compliance
Maintain awareness of MHRA/EMA/FDA/DEA, etc. regulatory actions that may affect company products.
Supports regulatory reporting and submissions as applicable.
Keep informed of all regulatory changes, rulings and current industry practices concerning Post Marketing Surveillance activities.
When appropriate, assist in regulatory inspections regarding client products and post marketing product surveillance activities
When appropriate, assist in regulatory notification or market correction activities (i.e. field alert / recall activities)
Initiate, author, revise or assist in the review of SOPs, and other cGMP documentation including but not limited to CAPA, Deviation, etc)

Experience & Knowledge Essential
Preferred Experience with TrackWise and APQR preferred.
Skills/Behaviors MS or Bachelors degree in a relevant scientific/engineering discipline with at least 3 years GMP industry experience, the majority of which has been gained in the Quality environment and includes manufacturing

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:
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 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: $63.15/hr.

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