Overview
Quality Assurance Team Lead Jobs in Morrisville, NC at Unit Dose Solutions
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
Senior QA Lead / Manufacturing CSA QA Responsibilities:
Key Responsibilities:
Has understanding of regulations pertaining to the implementation and use of computerized systems in all GxP areas
Participates in system implementation project teams to provide guidance on System Lifecycle activities and validation strategy to be followed using a risk-based approach based on FDA CSA.
Develop and Present the Quality Assurance Plan for a large multi-year manufacturing site based on FDA CSA approach.
Consults with Quality team members and relevant internal stakeholders to identify / define high risk areas with the intent on focusing on patient safety, product quality and data integrity
Identifies and escalates areas of risk or non-compliance to manager / leadership team
Provide support to regulatory inspection preparedness activities as needed
Requirements:
Bachelor’s degree and relevant GxP work experience
11+ years’ experience of relevant role experience
Resource must be a strategic, high-level thinker who knows CSV/CSA, and very strong in data integrity/ALCOA principles
Experience performing Quality Assurance function related to Computerized Systems / Infrastructure
Proficiency with regulations related to FDA / MHRA regulations
Experience with validation of Enterprise / Lab Computerized Systems
Quality metrics, dashboards, analysis and improvement programs
Ability to guide and ensure client compliance with industry best practices and regulations.
Proficiency in using Microsoft Office Applications
This is a hybrid role with onsite support requirements expected in Philidelphia, PH
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
Verista collects and processes personal data in accordance with applicable data protection laws. If you are a California Job Applicant, see the privacy notice for further details.
For more information about our company, please visit us at Verista.com
Title: Quality Assurance Team Lead
Company: Unit Dose Solutions
Location: Morrisville, NC
