6589 - Deviation Investigator / Validation Engineer

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

Responsibilities:

Deviation Investigator / CQV leads deviations investigations, root cause analysis, CAPA development, and change controls in the Pharma industry: 

• Lead deviation and out-of-specification (OOS) investigations, applying structured root cause analysis methods to determine the root cause. 

• Author deviation reports, and CAPA plans with clear, defensible rationale that meets data integrity (ALCOA+) standards and holds up to regulatory scrutiny. 

• Draft CAPA plans that are risk-appropriate, measurable, and linked to verified root causes.

Requirements

• Undergraduate Engineering/STEM degree preferred (mechanical, chemical, biomedical, etc.)
• 1-3 years' experience
• Some Pharma experience preferred
• Deviation investigation remediation and/or quality experience is a plus
• New college grads with internship experience encouraged to apply
• Proficiency using PC and Microsoft Office tools
• Outgoing personality with strong ability to communicate effectively with peers in clear, concise terms
• Ability to work as part of a team
• Strong problem-solving and critical thinking skills
• Excellent technical writing skills
• Excellent organizational and time management skills
• Strong attention to detail
• Strong interpersonal skills and clear communication capabilities
• Experience with and tolerance for high levels of challenge and change
• Onsite requirement in Indianapolis, IN

For US geography, the salary range for this position is shown below. The actual salary is dependent upon a variety of job-related factors such as professional background, training, work experience, location, business needs, market demand, and competitive market practice. Therefore, in some circumstances, the actual salary could fall outside of this expected range. This salary range is subject to change and may be modified in the future.

*Verista is an equal opportunity employer.

National (US) Range $69,300 — $102,623 USD

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