6507 - Document Controller / Associate CQV Engineer

Verista; Olde West Chester (OH); On-site; USD 59,000 - 85,000; Full time

Benefits offered by this job

Medical, Dental & Vision insurances

401(k) Retirement Plan

Paid Time Off

Tuition Reimbursement

Life Insurance

Job summary

Verista in West Chester, Ohio is seeking an experienced Document Controller to support document management in a regulated pharmaceutical manufacturing environment. You will manage creation, routing, review, approval, and archival of controlled documents in the EDMS, and ensure GDP/cGMP compliance.

The role requires hands-on Veeva experience, knowledge of cGMP/GDP, meticulous attention to detail, and ability to coordinate with Quality, Engineering, Validation, and Manufacturing teams onsite.

Qualifications

• Previous Document Control experience within pharmaceutical or other highly regulated life sciences.
• Hands-on experience with Veeva Vault QualityDocs or a similar Veeva document management application.
• Knowledge of cGMP and Good Documentation Practices (GDP).
• Experience managing controlled documents and electronic document workflows.
• Strong attention to detail with excellent organizational and time-management skills.

Responsibilities

• Manage the creation, routing, review, approval, issuance, revision, and archival of controlled documents within the EDMS.
• Utilize Veeva to manage document workflows, approvals, revisions, and document lifecycle activities.
• Ensure controlled documents are accurate, current, properly formatted, and maintained in accordance with established procedures and cGMP requirements.
• Support document control activities for SOPs, work instructions, specifications, protocols, reports, forms, and other GDP/GxP documentation.
• Coordinate document reviews and approvals with Quality, Engineering, Validation, Manufacturing, and other stakeholders.
• Track documents through the approval process and follow up with document owners and reviewers to ensure timely completion.
• Maintain document histories, revision records, effective dates, and appropriate archival of superseded documentation.
• Perform quality checks of documentation for completeness, accuracy, formatting, and compliance with GDP.
• Assist with document retrieval and preparation for internal audits, regulatory inspections, and project activities.
• Support continuous improvement of document control processes and procedures.

Skills

Document control

Regulatory compliance

Cross-functional collaboration

Attention to detail

Verbal and written communication

Tools

Veeva Vault QualityDocs

EDMS

Microsoft Office

Job description

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
  
  

We are seeking an experienced Document Controller to support document management and control activities within a regulated pharmaceutical manufacturing environment. This individual will be responsible for maintaining accurate, compliant, and controlled documentation while supporting Quality, Engineering, Validation, Manufacturing, and other cross-functional teams.

Document Controller Responsibilities

• Manage the creation, routing, review, approval, issuance, revision, and archival of controlled documents within the electronic document management system (EDMS).
• Utilize Veeva to manage document workflows, approvals, revisions, and document lifecycle activities.
• Ensure controlled documents are accurate, current, properly formatted, and maintained in accordance with established procedures and cGMP requirements.
• Support document control activities for SOPs, work instructions, specifications, protocols, reports, forms, and other GxP documentation.
• Coordinate document reviews and approvals with Quality, Engineering, Validation, Manufacturing, and other stakeholders.
• Track documents through the approval process and follow up with document owners and reviewers to ensure timely completion.
• Maintain document histories, revision records, effective dates, and appropriate archival of superseded documentation.
• Perform quality checks of documentation for completeness, accuracy, formatting, and compliance with Good Documentation Practices (GDP).
• Assist with document retrieval and preparation for internal audits, regulatory inspections, and project activities.
• Support continuous improvement of document control processes and procedures.
  
  

Requirements

• Previous Document Control experience within the pharmaceutical, biotechnology, or other highly regulated life sciences industry required.
• Hands-on experience with Veeva, preferably Veeva Vault QualityDocs or a similar Veeva document management application, required.
• Knowledge of cGMP and Good Documentation Practices (GDP).
• Experience managing controlled documents and electronic document workflows.
• Strong attention to detail with excellent organizational and time-management skills.
• Ability to manage multiple documents, priorities, and deadlines simultaneously.
• Strong written and verbal communication skills with the ability to work effectively across multiple functional groups.
• Proficiency with Microsoft Office applications.
• Ability to work onsite in West Chester, Ohio.
  
  

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: $58,550 USD - $84,905 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