Verista · 6 hours ago
6170 - Batch Disposition Associate / Quality Specialist
Verista is a company that partners with leading brands in the life science industry to address significant healthcare challenges. They are seeking a Quality Specialist to perform Quality Assurance support for drug product manufacturing, ensuring compliance with regulatory standards and facilitating timely batch disposition and release.
ComplianceHealth CareLife ScienceManufacturingPharmaceutical
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
Qualification
Required
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
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
Preferred
Experience supporting aseptic or parenteral manufacturing environments
Benefits
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
Company
Verista
Verista offers transformative compliance, automation, packaging solutions for the life sciences, pharmaceutical and manufacturing.
H1B Sponsorship
Verista has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (7)
2024 (4)
2023 (13)
2022 (6)
2021 (1)
Funding
Current Stage
Late StageRecent News
2023-12-22
2023-12-22
Company data provided by crunchbase