6170 - Batch Disposition Associate / Quality Specialist

Description

Verista’s 500 experts team up with the world’s most recognizable brands in the life science industry to solve their business needs. The nature of our business is to empower growth and innovation within the scientific community and to help researchers, organizations, and companies solve some of the world’s most pressing healthcare challenges. Verista provides innovative solutions and services that empower informed decision-making and are the result of our significant investment in our people and our capabilities.

Our ability to grow is driven by world-class people who thrive in a team environment and share our mission to enable life sciences clients to improve lives. Our talented and dedicated professionals are committed to making an impact every day.

Company Culture Guidelines & Values:

• We empower and support our colleagues


• We commit to client success at every turn


• We have the courage to do the right thing


• We encourage an inclusive environment where our colleagues feel respected, engaged, and challenged.


• We constantly acquire new skills and learn from our experiences to enhance our collective expertise

Quality Specialist Responsibilities:

• Perform Quality Assurance support for clinical and commercial drug product manufacturing, including thorough review of executed batch records, logbooks, equipment reports, environmental monitoring summaries, and Certificates of Analysis to support timely batch disposition and release


• Assess, investigate, and approve deviations, exceptions, non-conformances, and change controls, ensuring decisions align with Good Manufacturing Practices (GMP) and maintain a validated state of control


• Review, approve, and maintain QA-controlled documentation to ensure compliance with regulatory and quality system requirements and confirm equipment and processes are fit for use


• Analyze quality and manufacturing trend data to identify potential risks, determine the need for corrective and preventive actions (CAPA), and support continuous improvement initiatives


• Provide QA on-the-floor oversight, collaborating with Manufacturing Associates and cross-functional teams to resolve issues in real time and make timely, independent Quality and GMP decisions with minimal supervision

Job Requirements:

• Bachelor’s degree in an industry-related field (e.g., Life Sciences, Chemistry, Biology, Engineering, or a related discipline)


• 3+ years of experience in Quality Assurance, Quality Operations, or a regulated pharmaceutical, biotech, or medical device manufacturing environment


• Working knowledge of GMP regulations and quality systems, including deviation management, change control, CAPA, and batch record review


• Experience supporting aseptic or parenteral manufacturing environments preferred


• Strong attention to detail, sound decision-making skills, and the ability to work independently while collaborating effectively with cross-functional teams


• Willingness to be on-site, full-time in Durham, NC

Benefits

Why Choose Verista?

• High growth potential and fast-paced organization with a people-focused culture


• Competitive pay plus performance-based incentive programs


• Company-paid Life, Short-Term, and Long-Term Disability Insurance.


• Medical, Dental & Vision insurances


• FSA, DCARE, Commuter Benefits


• Supplemental Life, Hospital, Critical Illness and Legal Insurance


• Health Savings Account


• 401(k) Retirement Plan (Employer Matching benefit)


• Paid Time Off (Rollover Option) and Holidays


• As Needed Sick Time


• Tuition Reimbursement


• Team Social Activities (We have fun!)


• Employee Recognition


• Employee Referral Program


• Paid Parental Leave and Bereavement

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For more information about our company, please visit us at Verista.com