Talent.com
Katalyst HealthCares & Life Sciences
CQV Documentation SpecialistKatalyst HealthCares & Life Sciences • Philadelphia, NC
No longer accepting applications
CQV Documentation Specialist

CQV Documentation Specialist

Katalyst HealthCares & Life Sciences • Philadelphia, NC
30+ days ago
Job type
  • Full-time
Job description


Summary:

  • The CQV Documentation Specialist is responsible for creating, reviewing, and maintaining high-quality documentation that supports commissioning, qualification, and validation (CQV) activities for manufacturing process equipment in GMP-regulated pharmaceutical and biopharmaceutical environments. This role ensures all documentation—protocols, reports, SOPs, risk assessments, and equipment lifecycle documents—is accurate, compliant, and audit-ready.

Roles & Responsibilities:

  • Prepare, write, and revise CQV documents including URS, DQ, IQ, OQ, PQ protocols and summary reports.
  • Draft equipment and system-specific documentation for reactors, bioreactors, chromatography skids, filtration systems, buffer prep systems, filling lines, HVAC, WFI/clean utilities, CIP/SIP systems, etc.
  • Create validation test scripts, data sheets, and acceptance criteria aligned with cGMP and regulatory expectations.
  • Convert complex engineering, automation, and process inputs into clear, structured, user-friendly documentation.
  • Develop and maintain equipment lifecycle documentation such as FAT/SAT reports, calibration records, and equipment traceability matrices.
  • Support development of P&IDs, functional specifications, and system descriptions by drafting corresponding narrative documents.
  • Author, revise, and finalize equipment-related SOPs, work instructions, and operational guidelines for manufacturing teams.
  • Perform and document risk assessments (FMEA, risk ranking, impact assessments) for CQV and equipment qualification.
  • Support change control processes by preparing impact assessments and technical rationales.
  • Ensure documentation complies with FDA, EMA, ICH Q/Q/Q/Q, GAMP , and cGMP requirements.
  • Prepare documentation packages for internal audits, vendor audits, and regulatory inspections.
  • Ensure all CQV documentation is inspection-ready, traceable, and fully aligned with qualification requirements.
  • Experience in CQV, validation, or documentation within GMP-regulated pharma/biopharma settings.
  • Strong understanding of equipment commissioning, qualification, and validation principles.
  • Excellent technical writing skills with the ability to interpret engineering drawings, P&IDs, and automation logic.
  • Familiarity with pharmaceutical manufacturing processes (bioreactors, filtration systems, chromatography, fill-finish, utilities, etc.).
  • Experience with document management systems (Veeva, MasterControl, Documentum, etc.) preferred.
  • Knowledge of GMP, GAMP , CFR Part , and validation lifecycle principles.

Create a job alert for this search

CQV Documentation Specialist • Philadelphia, NC

Similar jobs

Work From Home - Product Specialist - $45 per hour

GL1Rockingham, North Carolina
$45.00 hourly
Remote
Part-time +1

Product Testers are wanted to work from home nationwide in the US to fulfill upcoming contracts with national and international companies.We guarantee 15-25 hours per week with an hourly pay of bet... Show more

 • Promoted

Consumer Research Associate (Remote)

GL IncRockingham, North Carolina
$15.00 hourly
Remote
Part-time +1

Product Testers are wanted to work from home nationwide in the US to fulfill upcoming contracts with national and international companies.We guarantee 15-25 hours per week with an hourly pay of bet... Show more

 • Promoted

Work-From-Home Product Beta Tester - $45 per hour

Great LionRockingham, North Carolina
$45.00 hourly
Remote
Part-time +1

Product Testers are wanted to work from home nationwide in the US to fulfill upcoming contracts with national and international companies.We guarantee 15-25 hours per week with an hourly pay of bet... Show more

 • Promoted

Work from Home - Part Time - Data Entry - $45 per hour

GL Inc.Rockingham, North Carolina
$45.00 hourly
Remote
Part-time +1

Product Testers are wanted to work from home nationwide in the US to fulfill upcoming contracts with national and international companies.We guarantee 15-25 hours per week with an hourly pay of bet... Show more

 • Promoted

QA Technician

NovipaxRockingham, NC, United States
Full-time

Headquartered in Oak Brook, Illinois, with plants strategically located across the USA, Novipax is safeguarding the future by partnering with fresh protein and produce processors, grocery retailers... Show more

 • Promoted

FT Data Entry Assistant - Transportation Safety (Work From Home)

ProSidianRockingham, NC, United States
Remote
Full-time

Administrative Assistant / Fully Remote] - Anywhere in U.Competitive pay / Medical, dental and vision / 401k / PTO - As a Data Entry Assistant you'll: Perform accurate and timely data entry tasks, ... Show more

 • Promoted

Hyatt Careers in Candor, NC

HyattCandor, NC, United States
Full-time

Hyatt is hiring front desk agents, housekeepers, food and beverage staff, and guest services managers.Competitive wages with comprehensive benefits and complimentary or discounted hotel stays world... Show more

 • Promoted

Production Associate I

LaticreteHamlet, NC, United States
Full-time

Job Opportunity at LATICRETE International.Are you looking for a new challenge? Passionate about innovation? Want to work for a global company that values integrity, teamwork, and loyalty?.At LATIC... Show more

 • Promoted

Medical Courier

Blue Collar StaffingMcColl, SC
Full-time

We're looking for a reliable and professional Medical Courier to transport time-sensitive medical materials — including lab specimens, pharmaceuticals, medical equipment, and patient records — betw... Show more

 • Promoted

Remote Data Entry - Product Support - $45 per hour

GL Inc.Rockingham, North Carolina
$45.00 hourly
Remote
Part-time +1

Product Testers are wanted to work from home nationwide in the US to fulfill upcoming contracts with national and international companies.We guarantee 15-25 hours per week with an hourly pay of bet... Show more

 • Promoted

Product Tester – Remote

OCPARockingham, North Carolina, US
$18.00 hourly
Remote
Part-time +1

Product Testers are wanted to work from home in the UK to fulfill upcoming contracts with local and international companies.We guarantee 15-25 hours per week with an hourly pay of between £18/hr.Th... Show more

 • Promoted

Work From Home

Remote JobsMcColl, SC
Remote
Full-time

Remote Jobs are now available in your area.This position is a work from home position.You will not need to come into the office.Benefits: Health Insurance, 401K, Vacation& PTO.Apply now! Work f... Show more

 • Promoted

Best Buy Jobs in Candor, NC

Best BuyCandor, NC, United States
Full-time

Best Buy is hiring sales consultants, Geek Squad agents, inventory specialists, and warehouse associates.Competitive wages with comprehensive benefits and generous employee discounts.Hands-on train... Show more

 • Promoted

Work-From-Home Product Quality Assurance - $45 per hour

Great LionRockingham, North Carolina
$45.00 hourly
Remote
Part-time +1

Product Testers are wanted to work from home nationwide in the US to fulfill upcoming contracts with national and international companies.We guarantee 15-25 hours per week with an hourly pay of bet... Show more

 • Promoted

CQV Documentation Specialist

Katalyst Healthcares and Life SciencesRockingham, NC, United States
Full-time

Summary:The CQV Documentation Specialist is responsible for creating, reviewing, and maintaining high-quality documentation that supports commissioning, qualification, and validation (CQV) activiti... Show more

 • Promoted

Certified Nursing Assistant (CNA)

Autumn Care of BiscoeBiscoe, NC, United States
Full-time

Join a team where your compassion and dedication as a nursing assistant in a skilled nursing facility brings comfort and connection to those who need it most!.Flexible Pay Options Choose On-Demand... Show more

 • Promoted

Parts Specialist

O'Reilly AutomotiveBennettsville, SC, United States
Full-time

The Parts Specialist will provide all retail and installer customers with a high level of service.This position will also support store management in the accomplishment of assigned tasks.Bilingual ... Show more

 • Promoted

Behavioral Health Technician / Mental Health Support Specialist (Per Diem)

PhaxisRockingham, NC, United States
Full-time

Behavioral Health Technician / Mental Health Support Specialist (Per Diem).Location: Rockingham, North Carolina Up to $21/hr | Flexible Scheduling | Day & Night Shifts Available We are currently hi... Show more

 • Promoted

Remote Consumer Feedback Participant

GL IncRockingham, North Carolina
$15.00 hourly
Remote
Part-time +1

Product Testers are wanted to work from home nationwide in the US to fulfill upcoming contracts with national and international companies.We guarantee 15-25 hours per week with an hourly pay of bet... Show more

 • Promoted

WORK-FROM-HOME Customer Service - Product Support - $25-$45 per hour

GL1Rockingham, North Carolina
$25.00 hourly
Remote
Part-time +1

Product Testers are wanted to work from home nationwide in the US to fulfill upcoming contracts with national and international companies.We guarantee 15-25 hours per week with an hourly pay of bet... Show more