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Actalent ยท 2 days ago
QA Specialist
Parsippany, NJ
Contract
Hybrid
Senior Level
6+ years exp
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Responsibilities
Provide Quality oversight to biologics Contract Manufacturing Organization (CMO) operations including but not limited to review/approval of CMO batch records, disposition, deviations, CAPAs, change controls, and inspection management.
Routinely review and approve Certificates of Assurance (CoA) and Certificates of Compliance (CoC), routine manufacturing, environmental monitoring and quality control data for in-process and finished products.
Exercises judgment within well-defined and established procedures and practices to determine appropriate action with minimal supervision.
Perform Quality Assurance activities to ensure compliance with internal processes and procedures and applicable US and international regulatory requirements in support of current Good Manufacturing Practices (cGMP) operations.
Accountable for extracting, consolidating, and analyzing data within a specific area of concentration.
Demonstrates an ability to communicate effectively with peers in CMO Organization.
Maintain routine systems, programs, and processes to ensure high quality products and compliance with cGMP.
Interface with CMO and site client groups and within the Gilead network to address investigations and quality issues requirements.
Effectively communicate with external suppliers to address documentation and compliance issues.
Develops solutions to more complex problems and identifies deviations from accepted practice and evaluates impact assessment as required.
Write, implement, review, and/or approve changes to controlled documents (e.g., SOPs, specifications, batch records, etc.) to ensure quality objectives are met.
Track, trend, and report CMO metrics and support site QMR and Executive QMR processes.
Participate post-inspection risk assessments of CMO regulatory inspections, identify, and implement improvements, as needed.
Qualification
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Required
Demonstrates proficiency in Good Manufacturing Practices (GMPs) and/or Good Laboratory Practices (GLPs).
6+ years of experience
Demonstrates thorough knowledge of FDA / EMEA, other international standards and quality systems, and the interface with other functions like manufacturing, distribution, and maintenance.
Demonstrates strong knowledge of six sigma, LEAN and root cause analysis tools used for identifying and correcting deviations.
Demonstrates excellent verbal communication, technical writing, and interpersonal skills.
Knowledge of Six Sigma, Define-Measure-Analyze-Improve-Control (DMAIC) methodology, performance measures and quality improvement statistical methods are beneficial.
Working knowledge of Risk Management tools (e.g., Hazard Analysis and Critical Control Points (HACCP) and / or Failure Mode Effects Analysis (FMEA)) is beneficial.
Preferred
Prior experience in pharmaceutical industry is preferred.
Preferred experience working with CMOs.
Company
Actalent
Actalent is an engineering and sciences service company.
5,001-10,000 employees
H1B Sponsorship
Actalent has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Trends of Total Sponsorships
2023 (31)
2022 (63)
2021 (20)
Funding
Current Stage
Late StageLeadership Team
Scott Anderson
Chief Financial Officer
Alison Deming Bucek, SPHR, SHRM-SCP
Human Resource Business Partner
Recent News
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