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Form of workVerista’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 expertiseSenior 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 scheduledRequirementsRequirements-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 #LI-RC1BenefitsWhy 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 Savings Account 401(k) Retirement Plan (Employer Matching benefit) Paid Time Off (Rollover Option) and Holidays Leadership development training, career planning, and tuition reimbursement Team Social Activities (We have fun!) Employee Recognition Employee Referral Program Paid Maternity, Parental Leave and BereavementVerista is a leading business, technology and compliance company that enables clients to improve health and improve lives. We help clients solve their most critical and complex challenges across the GxP lifecycle, from preclinical and clinical to commercialization, manufacturing, and distribution.
This experience brings together decades of knowledge, the most advanced engagement platforms, as well as transformative technologies. This allows clients to benefit from the ease, efficiency, and trust that results from working with one partner who excels across specialties.For more information about our company, please visit us at or follow us on .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.
