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5766 -Technical Writer (Pharma) / Validation Analyst

North Wales, PA

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 Technical Writer with a strong background in pharmaceutical documentation—specifically supporting large molecule, biologics, and Quality Control (QC)-focused lab operations. The ideal candidate will have hands-on experience developing GxP-compliant documentation and working knowledge of laboratory processes, terminology, and equipment validation. This role is integral in ensuring accurate and regulatory-compliant documentation of lab activities and results, including the generation of Certificate of Analysis (CoA) reports.

Technical Writer Responsibilities:

  • Develop, author, and maintain GxP-compliant laboratory documentation including SOPs, protocols, and reports
  • Prepare and format Certificate of Analysis (CoA) documents for biologics and other QC test results
  • Interpret and document laboratory test results, ensuring accuracy and regulatory compliance
  • Collaborate with QC scientists and analysts to ensure alignment on technical terminology and lab data representation
  • Contribute to the validation documentation for laboratory equipment as needed
  • Ensure all documents are prepared in accordance with internal quality standards and applicable regulatory guidelines (e.g., FDA, ICH)
  • Support audits and inspections by providing documentation as required

Requirements:

  • 3+ years of experience as a Technical Writer in the pharmaceutical or biotechnology
  • Proven experience supporting large molecule or biologics and QC-focused lab documentation
  • Strong understanding of GxP practices, laboratory operations, and equipment validation
  • Familiarity with scientific vocabulary related to analytical testing, biologics, and lab instruments
  • Excellent written and verbal communication skills
  • Ability to work independently with cross-functional lab and QA teams
  • Proficiency in Microsoft Word and document management systems (e.g., Veeva Vault, MasterControl) is a plus
  • Remote work is supported, but onsite presence in North Wales, PA is preferred

 

 

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

$80,465 - $125,000 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

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