Batch Record Reviewer /Data Analyst - 5088

Verista’s 600 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

Quality Assurance Batch Record Reviewer Responsibilities:

• Reviewing all project and system deliverables including but not limited to: Master Batch Records, plans, requirements, specifications, test protocols, scripts and associated execution deliverables, summary reports, and change controls
• Reviewing system operational and administration procedures to ensure they are adequate.
• Documenting any findings of non-compliance.
• Assisting with strategy regarding remediation activities.
• Assisting with review of remediation activities.
• Performs other duties as assigned.

Desired Skills:

• Strong understanding of quality systems and compliance requirements
• Have demonstrated experience in working with batch records and associated process/systems
• Preferred experience in manufacturing and/or quality setting
• Detail oriented with strong understanding of data integrity, GDP, and cGMP requirements
• Have worked with batch records and have familiarity with workings of cGMP manufacturing environment
• Life science or engineering degree with at least 5+ yrs of direct relevant exp.
• Use of TrackWise and ERP system is highly desired

If you are qualified, have leadership potential and a willingness to learn, Verista could be the right career choice for you!

Requirements

• BS in chemical, biomedical, or biochemical engineering, biological sciences, or related field/experience.

• 2-5 years relevant industry experience working in a cGMP environment.

• Working knowledge of cGMP manufacturing as well as regulatory regulations and requirements for biotechnology, pharmaceuticals, and medical devices in your toolbox.

• Experience with quality assurance tasks and remediation actives.

• Experience reviewing Master Batch Records and validation documents.
• Experience with documenting remediation activities.

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

For more information about our company, please visit us at Verista.com

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.

$50-57/hour

*Verista is an equal opportunity employer.