Senior Lead Quality Assurance Specialist - Contract Only-3553BC

Verista’s 700 experts team up with the world’s most recognizable brands in the life science industry to solve their business needs. Whether it’s 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

• You’ve earned your BS in chemical, biomedical, or biochemical engineering, biological sciences, or related field/experience.
• You’ve gained 2-10 years relevant industry experience working in a cGMP environment.
• You’ve 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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