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Veristas 700 experts team up with the worlds most recognizable brands in the life science industry to solve their business needs. Whether its compliance, quality management, verification, validation, automation, IT infrastructure, data analysis, manufacturing, or packaging, we deliver solutions that are right the first time.

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

Verista is currently seeking Validation Engineers with experience in facilities, equipment and process validation within a pharmaceutical or biotechnology manufacturing environment to support CQV (Commissioning, Qualification & Validation) activities.

Typical Responsibilities of a Senior Lead Quality Assurance Specialist: Kalamazoo, MI

Lab Test Plans
Manage Sample Handling
Review and QO Approval of Documents
Review and QO Approval of Change Controls
Release materials (Raw, API, DP)
QA Alerts
QO Memos
Review and QO Approval of deviations
Ensure that SOPs are being followed
Review and Approve Stability
Regulatory
o Packet Creation
o Reviews
o Query Responses
o Approvals
Coordination of QO Resources
Coordination with Development Team (Product and Analytical)
Discussions and Negotiations within Site and with R&D

Requirements

• Youve earned your BS in chemical, biomedical, or biochemical engineering, biological sciences, or related field/experience.
• Youve gained 2-10 years relevant industry experience working in a cGMP environment.
• Youve got working knowledge of cGMP manufacturing as well as regulatory regulations and requirements for biotechnology, pharmaceuticals, and medical devices in your toolbox.
• Experience quality assurance tasks and remediation actives.
• Experience reviewing Master Batch Records and validation documents.

Benefits

Because employees are the key to our success, Verista offers strong benefits and incentives including:

• Health, Dental, and Vision Insurance
• 401(k) Retirement Plan with a company match
• Paid Time Off Pay
• Tuition Reimbursement
• 9 Company Paid Holidays
• Paid Long Term & Short Term Disability Insurance
• Training and Development
• Paid Maternity Leave and Parental Leave
• Travel Bonus
• Employee Referral Program
• Tuition Reimbursement
• Marriage Leave
• Bereavement

*Verista is an Equal Opportunity Employer

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