Quality GxP Auditor Deviations- 3477BC

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

Senior Quality/GxP Auditor will be responsible for planning and conducting scheduled quality audits on behalf of clients. This position will also act as a Subject Matter Expert (SME) for GxP auditing and quality projects and will be responsible for supporting the development and management of the Quality Management and Auditing Service Line. This position is responsible for independently managing quality/GxP auditing deliverables and providing consulting services to clients as requested and scheduled

Requirements

Requirements-Onsite work in Allentown,PA- Duration 3 month +

Deviation Remediation Support:

o Develop and maintain Quality Item Prioritization List with Client.

o Evaluate, as directed by Client, open quality items via initial documentation, batch records, forms, SOPs, testing data, personnel interviews, process walk throughs, training program, trending and collaboration with area leaders.

o Drive Quality Remediation item identification, prioritization, and closure through the performance of gap assessments, root cause analysis, risk assessment execution and mitigation activity definition, and preventive action identification and definition.

o Support delivery of quality items including, but not limited to, investigation drafting, preventive action identification and definition, creation and/or revision of quality documentation and or procedures, establishing or revising training material, and change control management.

o Summarize scientific and data driven justification for closure of recommended additional actions regarding Quality items, if necessary and/or requested.

Required Knowledge/Experience

• B.S./B.A. in scientific discipline as a minimum.

• Minimum 3 years of GxP auditing experience in related industry.

• Minimum of 5 years of experience within Pharmaceutical / Biotech / Medical Device industry.

• Excellent knowledge of GxP regulatory requirements. • Demonstrated success in earning and maintaining a client’s confidence through appropriate planning, organizing, controlling, and directing of a project.

• Proven record of teamwork, problem solving, project tracking and facilitation of efficient communication between the client and the team. • Experience creating and working with high performance teams.

• Quality orientation and high attention to detail.

• Demonstrated ability to work with others and drive results. • Ability to think ahead and prepare sound action plans to achieve results.

• Audit certification from reputable agency - preferred Required Skills and Abilities

• Capacity to make independent sound decisions and independently manage priorities.

• Ability to interact in a professional and positive manner with clients and co-workers. • Exceptional communicator with strong persuasion skills and presentations.

• Excellent interpersonal and communication skills both written and verbal.

• Ability to write concise, accurate reports and other necessary documentation. • Ability to provide and receive constructive feedback.

• Ability to organize and manage multiple projects.

• Excellent analytical skills and the ability to assess large quantities of information efficiently and effectively.

• Ability to read, prepare and analyze data for development of reports; ability to sit and type for long periods of time; ability to read and assemble documents as required

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Benefits

Why Verista?

• High growth potential and fast paced organization with a people-focused culture
• Competitive pay plus performance-based incentive programs
• Company paid medical benefits
• Company paid Life, Short-Term, and Long-Term Disability insurances
• Dental & Vision insurances
• Health