Senior Quality GxP Auditor (3676SS)

Who are we:

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

Typical Project Accountabilities Include:

This position is a 2-month assignment, On site in Indianapolis.

• As part of our normal business we periodically receive inspections from regulatory bodies.
• In the near term, we have a resource gap and are seeking assistance with managing and formulating our official responses to these inspections.
• The technical input and responsibility will remain with IPM subject matter experts and Quality.
• Prepare and/or review documentation associated with deviations, investigations, OOS results, CAPA action plans and change controls which may include performing Failure Mode and Effects Analyses, root cause analyses and CAPA effectiveness checks as required
• Ensure all documentation complies with cGMP regulations and industry guidelines
• Manage audit responses, including assessing whether response meets regulatory authority, local authority, and requirements.
• Create official response to any Agency Attend Response Meetings – key stakeholders Extract knowledge and feedback Track open items in parking lot – gain closure
• Track and manage corrective and preventative actions (CAPAs) to completion and review for effectiveness as necessary
• Maintain performance metrics in alignment with KPIs
• Support GxP audit program as required

Requirements

• BA/BS and a minimum of 5+ years in Quality Assurance/Technical Writing.
• Experience drafting and responding to FDA 483 forms.
• Tech Writing experience
• Regulatory and Quality experience in Parenteral GMP environment
• Ability to track, follow up and close action items
• Ability to work off hours (this will be limited but might be expected)
• Sterility Assurance Experience
• Strong knowledge of GxP regulations, quality systems, and guidance documents
• Experience with managing contract testing organizations or contract manufacturing would be beneficial in this role.

Opportunity to be location flexible – Cambridge or remote.

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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

For more information about our company, please visit us at Verista.com or follow us on LinkedIn.

*Verista is an equal-opportunity employer.

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.

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