6018 - Annual Product Review Coordinator - Pharma / Validation Engineer
About The Position
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: We are seeking an entry level Annual Product Review (APR) coordinator in the Pharma industry. Also, this candidate would potentially support change management and deviation investigation. Employer will train hired resource on all skills required of this role.
Requirements
- Deviation investigation remediation experience is a plus but is not necessary
- Undergraduate Engineering/STEM degree preferred (mechanical, chemical, biomedical, etc.)
- 1-3 years' experience
- Salary dependent on experience
- Some Pharma experience preferred but not absolutely required
- 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 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
Nice To Haves
- Deviation investigation remediation experience is a plus but is not necessary
- Some Pharma experience preferred but not absolutely required
Responsibilities
- Review/analyze data and summarize/draw conclusions from the data
- Review charts and identify any trends- if there is upward/downward visual trend on chart, investigate for root cause
- Present to lead team and ability to interact multiple areas including Sr. Director level
- Review data/documents and ability to compare if there are any discrepancies/updates required.
- Review data/documents and pull applicable info into iAPR or contact SMEs to pull data needed
- Review changes/deviations for impact to validated state, and be able to speak on any trends
Benefits
- 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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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Number of Employees
11-50 employees
