Scalence L.L.C. · 2 days ago
Senior QA Compliance Specialist
Indianapolis, IN
Full-time
Hybrid
Senior Level, Lead/Staff
$48.60/hr - $66.73/hr
8+ years expScalence L.L.C. is a company focused on implementing robust Quality Systems for their RLT Indianapolis site. The Senior QA Compliance Specialist is responsible for developing and overseeing quality systems, facilitating training, and ensuring compliance with regulatory requirements and inspections.
Information Technology & Services
Responsibilities
Supports the development and oversight of robust quality systems, including both implementation and operation at site level
Leads the site level Quality Management Review (QMR) program including monitoring and reporting key performance indicators, as appropriate
Works with the management team to implement and execute the Inspection Readiness program, including Client Corporate Inspections and Global Health Authority Inspections
Facilitates training on all QA Compliance programs
Supports management to implement and maintain the following programs: Training and Qualification, Quality Management Review (KPIs), Annual Product Quality Review (APQR), Compliance Alerts, Market Actions and Client Global document assessments required to be performed at the site level
Contributes significantly to the site inspection preparation, program management, response, and commitment process
Escalates high quality risks per procedure and supports agency notifications such as Field Alerts
Performs duties as assigned to ensure compliance to global and local regulations
Represent QA Compliance on project teams and in meetings
Support the continuous improvement and oversight of QA Compliance programs and identifies and implements new technologies to improve the compliance and efficiency of QS operations
Adheres to all GMP requirements
Other related duties as assigned
Qualification
Required
8+ years of experience in a GMP Biopharmaceutical environment
2+ years of experience in a Quality Assurance role
Experience reviewing systems and analyze data (paper or electronic) to identify specific compliance and data consistency issues
Previous Quality Assurance experience required, including Data Integrity (ALCOA+) compliance
Ability to apply a phase appropriate, risk-based approach to QA operational decisions
Experience supporting cGMP manufacturing operations through administration and enforcement of the Quality Management System
Working knowledge of cGMP/ICH/FDA/EU regulations and guidelines and experience in US and international regulatory agency inspections a plus
Proficient in using Client applications (MS Word, MS Excel, MS PowerPoint)
Strong follow-up and organizational skills
Direct experience reviewing and/or authoring standard operating procedures
Ability to work well independently and within a team
Excellent oral and written communication skills with technical writing experience required
B.S. degree, preferably in Life Sciences, Chemistry, or related relevant degree
Preferred
Previous experience in QA Compliance including self-inspections
Experience with radiopharmaceutical therapies a plus
Company
Scalence L.L.C.
In today’s dynamic and competitive market, success hinges on mastering three key areas: Data Intelligence, Business Resilience, and Digital Experience.
501-1000 employees
Funding
Current Stage
Late StageCompany data provided by crunchbase