Senior QA Associate

Who We Are: 

At Veranova, we believe people are our most important asset, and we are dedicated to building the most talented and diverse workforce in our industry. Our commitment to uncompromising focus on quality, compliance, safety, and excellence in delivery shapes everything we do. We are not just looking for skills; we are seeking innovative individuals who have a mindset open to learning and growth, and a desire to make a difference.

Veranova is a global leader in the development and manufacturing of complex active pharmaceutical ingredients (APIs) for pharma and biotech customers. With deep technical expertise and impressive flexibility, we develop solutions and processes that support and accelerate innovation. 

Join us on our mission to enable current and next-generation therapeutics to improve and save the lives of patients. 

Role Overview:

The Senior QA Associate will perform on the floor walkthroughs of Manufacturing and Quality Control areas to drive Inspection Readiness activities. They will also perform review and release of Active Pharmaceutical Ingredients (APIs) in support of clinical and commercial product manufacturing, as well as assist in the development, implementation, and maintenance of quality systems and other Quality Assurance activities. This person must also maintain a high level of strict GMP compliance. 

Core 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. 

Qualifications:

• 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).

Our Commitment:

How to Apply: 

At Veranova, we are on a mission to meet people that believe in our values and can contribute to the team in a variety of ways. Please visit www.veranova.com to view all open roles and join our Talent Community to stay connected and learn about opportunities as they arise. 

We value a range of experiences and perspectives. If you want to be part of improving and saving the lives of patients, we encourage you to apply regardless of whether you meet every qualification listed. 

If you are a veteran, first responder, or in the process of transitioning from service member to civilian life, we encourage you to apply. Your experience brings invaluable skills and insights that can contribute to our team.

For applicants who may require a reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email to talentacquisition@veranova.com in order to confirm your request for an accommodation.  Please include the job number, title, and location of role. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Veranova employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.

Additional Information:

Applicants for this role must be authorized to work in the United States without further employer sponsorship.

Agency and Search Firm Representatives: Veranova does not accept unsolicited resumes from agencies and/or search firms for this job posting. 

Important Notice Regarding Recruitment Scams: Veranova is committed to providing a professional and secure recruitment experience for all applicants. Unfortunately, fraudulent job postings and recruitment scams are becoming more prevalent.  We want to ensure that all candidates are aware of potential scams. Please see our notice here.

• Legitimate communications from Veranova will only come from official email addresses using our domain: @veranova.com.
• Legitimate LinkedIn communications will only come from active Veranova employees.
• Veranova will never ask candidates for sensitive personal information during the application process (e.g., bank account details or social security number).
• Veranova will never ask candidates for payment (e.g., for equipment, training, or background checks).

If you have any doubts or concerns about the authenticity of a job posting, please reach out to our HR department: pharm.hr@veranova.com (US) or UKHR@veranova.com (UK).

All your information will be kept confidential according to EEO guidelines.

Veranova is an Equal Opportunity Employer. It is the policy of Veranova to provide equal employment access and opportunity to all persons regardless of age, race, color, national origin, religion, sex, sexual orientation, gender identity and/or expression, physical or mental disability, genetic information, citizenship, marital status, veteran status, or any other characteristic protected by federal, state, or local law.

All applications are carefully considered, and your details will be stored on our secure Application Management System. This is used throughout Veranova for the selection of suitable candidates for our vacancies as they arise. Veranova respects your privacy and is committed to protecting your personal information. For more information about how your personal data is used please view our privacy notice.