6589 - Deviation Investigator / Validation Engineer Indianapolis, IN

Verista; Indianapolis (IN); Sur place; USD 69 000 - 103 000; Plein temps

Avantages offerts par ce poste

Life Insurance

Disability Insurance

Health Savings Account

Paid Time Off

Tuition Reimbursement

Parental Leave

Bereavement

Employee Referral Program

Résumé du poste

Verista, based in Indianapolis, IN, seeks a Deviation Investigator / CQV lead to manage deviation investigations, root-cause analysis, CAPA development, and change controls in the Pharma sector. Onsite in Indianapolis, you will collaborate with cross-functional teams to meet regulatory expectations and ensure data integrity.

Requirements include an undergraduate STEM degree, 1-3 years of experience, strong writing and communication skills, and proficiency with MS Office.

Qualifications

• Undergraduate Engineering/STEM degree preferred
• 1-3 years' experience
• 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
• 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

Responsabilités

• Lead deviation and OOS investigations with root-cause analysis
• Author deviation reports and CAPA plans with defensible rationale
• Draft CAPA plans that are risk-appropriate and linked to verified root causes

Connaissances

Root cause analysis

Technical writing

Communication

Team collaboration

Problem solving

Formation

Undergraduate Engineering/STEM degree

Outils

Microsoft Office

Description du poste

Indianapolis, IN

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 / CQVleads 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
• 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

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.
• Supplemental Life, Hospital, Critical Illness and Legal Insurance
• Health Savings Account
• 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

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As set forth in Verista, Inc.’s Equal Employment Opportunity policy,we do not discriminate on the basis of any protected group status under any applicable law.

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