Veranova

Analyst

• 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.

Senior Quality Analyst

QA Engineer

• Responsible for managing Quality Assurance group and directs day-to-day operation to ensure quality Assurance for Devens and North Andover sites.
• This position is responsible for implementing and managing cGMP compliant practices in the as well as deploying functional strategy within the department.
• Providing framework for effective teamwork, setting objectives, and ensuring development of Quality Assurance personnel.
• Evaluate and implement systems, methods, techniques, and solutions to complex quality compliance issues.
• Host all regulatory agency and client audits.
• Interface with Clients for project planning, and problem resolution with a strong customer service approach.
• Recommends and leads implementation of critical compliance systems and provide recommendations to operations management.
• Recommends the stop of any manufacture and/or distribution of a product if necessary.
• Manages the review, approval, and delivery of Quality Assurance related training content and programs including new Quality Assurance initiatives for continuous improvement.
• Analyses trends associated with data, proficiency testing, equipment/supply/reagent defects and develop solutions as appropriate.
• Directs and advises the Quality Assurance group to achieve long and short-term goals and objectives.
• Develops, improves, and revises Standard Operating Procedures (SOPs) and Quality Policies as required/needed.
• Assures the qualification of suppliers and vendor management program.
• Ensures the review and approval of equipment qualification protocols and results.
• Participates in internal auditing programs to assure compliance with regulatory requirements and company standards.
• Partner collaboratively with Production, Maintenance, QC for all Quality decisions.
• To carry out any other duties which are within the employee’s skills and abilities whenever reasonably instructed.

Associate Director, Quality Assurance – CDMO

Manager

• Lead and manage all aspects of shift operations ensuring safe, efficient, and compliant manufacture of products
• Accountable for achieving production targets, optimizing resources, and driving continuous improvement initiatives
• Ensure production schedule targets and plans are met
• Communicate key details to the Associate Director, Production, including deviations from the manufacturing schedule, quality, EHS, and resource issues
• Work with all manufacturing areas to ensure standardisation of processes
• Manage resources to optimise utilisation and achieve operational targets
• Maintain control and ensure effectiveness in EHS, cGMP, and company policies and procedures
• Provide effective communication up and down the management line and across departments
• Participate and/or lead improvement projects as required

Production Shift Manager

Software Engineer

• Work closely with production leadership to execute one or two specific projects which they will own from start to finish.
• Complete a 5S project.
• Spend time learning how a pharmaceutical manufacturing operation works from raw materials through final product packaged.
• Carry out any other duties which are within the intern’s skills and abilities whenever reasonably instructed.

Senior Quality Analyst

Associate Director, Quality Assurance – CDMO

Production Shift Manager

Chemical Engineering Internship