14 Senior Quality Compliance Specialist Jobs in Lexington, MA
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Senior Quality Compliance Specialist
$88k-109k (estimate)
Full Time | Business Services
2 Weeks Ago
LanceSoft Inc is Hiring a Senior Quality Compliance Specialist Near Lexington, MA
Actual Job Title: Biologics & Plasma Complaint Lead
Job DescriptionRecommended experience: 0-3 years for Associate level, 4-7 years Intermediate level, and 8+ for Senior level hires
Responsibilities
Job DescriptionRecommended 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.
- 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
- Preparation as per applicable SOP
- Supports Global System for Product Quality Reviews/Annual Product Review
- Coordinate APQR Review meetings
- Create and Track APQR elements.
- Follow-up on pending items and facilitate discussions to resolve outstanding items
- 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.
- Provide QA input on compliance issues concerning Product Quality Reviews.
- 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.
- MS or Bachelor’s 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
Job Summary
JOB TYPE
Full Time
INDUSTRY
Business Services
SALARY
$88k-109k (estimate)
POST DATE
06/08/2024
EXPIRATION DATE
06/30/2024
WEBSITE
lancesoft.com
HEADQUARTERS
HERNDON, VA
SIZE
500 - 1,000
FOUNDED
2000
TYPE
Private
CEO
DIVYA GANDHI
REVENUE
$200M - $500M
INDUSTRY
Business Services
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About LanceSoft Inc
LanceSoft is a provider of application development, management outsourcing and data-warehousing services to the aerospace and automotive sectors.
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