What are the responsibilities and job description for the 5445 - Senior Quality Specialist/CQV position at Verista, Inc.?

Job Description

Description

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

Senior Quality Specialist / CQV Responsibilities :

Independently define and lead Quality / CSV Project.

Provide technical guidance and leadership to lesser experienced team members.

Complete review of previous assessments completed by third parties and established / drafted client documentation to drive development of a complete Validation Inventory List and Project Plan.

Lead project in its entirety.

Develop and maintain a project plan / Gantt with deliverables and resource assignments.

Maintain an inventory list of documents and their status throughout the project.

Development and Delivery of Artifacts

Oversee additional team members and drive delivery of high-quality documentation

Delivery of new documents and / or update current documents and align to Client documentation format per defined Validation Inventory List and Project Timeline.

Preparation and presentation of project status reports.

Liaise with business unit quality / compliance functions to ensure regulatory requirements are well understood and documented.

Requirements :

Travel to site in Grove City, Ohio 5 to 7 times based upon project demands.

Demonstrated project leadership capabilities.

Obvious business maturity and interpersonal skills to be able to effectively communicate and collaborate.

Experience and capability of effectively communicating requirements (written and orally) with a rationale to different levels of the client's organization.

Ability to mentor and guide lesser experienced team members.

Ability to communicate effectively with clients.

Proven ability to identify areas of business expansion and report to the management team for follow-up.

Intermediate Microsoft Project capabilities.

Excellent knowledge of Quality system principles; FDA Quality System Regulations (cGMP); ISO 13485 Quality system standards for medical devices or ISO 9001 Quality Management Systems and IS014971 Risk Management Systems required.

Obvious business maturity and interpersonal skills to be able to effectively communicate and collaborate.

Experience and capability of effectively communicating requirements (written and orally) with a rationale to different levels of the client's organization.

5-8 years of role relevant experience required.

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.

National (US) Range

70,491—$129,000 USD

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

Verista collects and processes personal data in accordance with applicable data protection laws. If you are a California Job Applicant, see the privacy notice for further details.

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

Salary : $70,491 - $129,000

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5445 - Senior Quality Specialist/CQV

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