Veranova

Senior Quality Analyst

Veranova

full-time

Posted on:

Location Type: Office

Location: Devens • Massachusetts • United States

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Job Level

Senior

About the role

  • Perform on the floor walkthroughs of Manufacturing and Quality Control areas to drive Inspection Readiness activities.
  • Perform review and release of Active Pharmaceutical Ingredients (APIs) in support of clinical and commercial product manufacturing.
  • Assist in the development, implementation, and maintenance of quality systems and other Quality Assurance activities.
  • Maintain a high level of strict GMP compliance.
  • Support Manufacturing and Quality Control operations on and off the floor, by providing QA support to operations in compliance with cGMP, ICH, and ALCOA+ principals.
  • Collaborate with manufacturing operators on the resolution of issues, non-conformities, and deviations.
  • Review of Executed Master Batch Records and provide documentation guidance for completeness, compliance, and accuracy to support lot disposition.
  • Perform Batch Disposition and Lot Release activities.
  • Recommend the stop of manufacture and/or distribution of product if necessary.
  • Support issuance activities for Master Batch Records and other records, as needed.
  • Perform GMP Walkthroughs for all areas of the site per procedure.
  • Perform Product Change Over (PCO) activities for the production suites.
  • Review of Trackwise records pertaining to deviations, investigations, CAPAs, CRMs and Customer Complaints.
  • Write and revise Standard Operating Procedures (SOPs) as required.
  • Initiate and participate in process improvement activities for quality processes to enhance compliance and efficiency.
  • Work directly with production, project management, and quality control to ensure that deliverables meet quality requirements.
  • Represent the department during client audits and FDA inspections.
  • Assist with overseeing QA Associate I and QA Associate II personnel.
  • Provide guidance and training for other Quality Assurance staff in the accomplishment of Quality Assurance operation activities.
  • Carry out any other duties which are within the employee’s skills and abilities whenever reasonably instructed.

Requirements

  • Required BS in a scientific discipline or equivalent with a minimum of 5-7 years’ experience in an FDA regulated industry or MS in a scientific discipline or equivalent with a minimum of 3-5 years’ experience in an FDA regulated industry.
  • Experience with Quality Assurance oversight and support for all phases of clinical trials.
  • Experience with supporting On the Floor Walkthroughs of Manufacturing areas.
  • Experience with performing Batch Record Review, Disposition and Release activities.
  • Experience with Active Pharmaceutical Ingredients (APIs).
  • Experience working with Clients, direct facing and email communications.
  • Demonstrate confidence in knowledge of Good Manufacturing Practice (GMP) regulations.
  • Knowledge and previous experience with GMP, ICH Q7, and 21 CFR Part 11.
  • Good understanding in Quality systems, Analytical, Manufacturing.
  • Expertise in FDA regulations, GMPs, and Quality Systems relevant to the manufacture of pharmaceuticals.
  • Experience mentoring and training staff members in a Quality department.
  • Experience with Microsoft Office and other complex computer software.
  • Experience with commercial phase pharmaceuticals.
  • Strong problem-solving skills and the ability to make decisions quickly.
  • Excellent written and verbal communication skills.
  • Strong collaboration background for providing on the floor support to key areas of the site.
  • Strong technical writing skills.
  • Proficiency in Microsoft Office Suite (Excel, Word, PowerPoint).
Benefits
  • Comprehensive health & Wellness benefits.
  • Access to mental health resources and wellness programs.
  • Generous PTO and holiday pay policies.
  • Comprehensive total compensation package that includes competitive base salary.
  • Defined Contribution Pension program.
  • Eligibility for performance-based bonuses.
  • Attractive 401(k) Plan with company match.
  • Opportunities for continuous learning through LinkedIn Learning, workshops, conferences, and mentorship.
  • Tuition Assistance for Undergraduate and Graduate degree programs.
  • An inclusive culture integral to company values.
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
Quality AssuranceBatch Record ReviewDispositionRelease activitiesActive Pharmaceutical Ingredients (APIs)GMP complianceQuality systemsTechnical writingProcess improvementAnalytical skills
Soft Skills
Problem-solvingDecision makingCollaborationCommunicationMentoringTrainingLeadershipInterpersonal skillsAttention to detailAdaptability