Veranova · 18 hours ago
Senior Quality Analyst Associate
Devens, MA
Full-time
Onsite
Mid, Senior Level
3+ years expVeranova is a global leader in the development and manufacturing of complex active pharmaceutical ingredients (APIs) for pharma and biotech customers. The Senior Quality Analyst Associate will perform on the floor walkthroughs of Manufacturing and Quality Control areas, drive Inspection Readiness activities, and support the review and release of APIs in compliance with GMP standards.
BiotechnologyHealth CareManufacturingPharmaceutical
No H1B
Responsibilities
Support Manufacturing and Quality Control operations on and off the floor, by proving 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 both on the floor and off the floor 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, which may include revision of QA relevant SOPs and review and/or approval of site wide SOPs and other documents
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
Assist in the scheduling and maintenance of Quality Assurance activities and systems
Provides guidance and training for other Quality Assurance staff in the accomplishment of Quality Assurance operation activities
To carry out any other duties which are within the employee’s skills and abilities whenever reasonably instructed
Qualification
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 one or more of the following areas: 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)
Preferred
Experience with Trackwise and Master Control (preferred)
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.
Company
Veranova
Veranova develops and manufactures active pharmaceutical ingredients(APIs).
501-1000 employees
Funding
Current Stage
Late StageTotal Funding
unknown2022-06-01Acquired
Leadership Team
Mike Riley
Chief Executive Officer
Jose Ibietatorremendia
SVP, General Counsel & Secretary
Recent News
2025-08-01
Company data provided by crunchbase