Documentation Specialist
Colgate-Palmolive · Hodges, SC · Yesterday
On-siteAdministrative$70k–$88k/yrFull-time
Responsibilities
- Creates and maintains Plant Wide Standard Operating Procedures & associated forms and documents
- Manages and updates document archives for Quality related documents according to company policy
- Reviews and maintains master batch records and associated documents used to support product releases
- Performs daily releases of finish product batches to meet Positive Release Time KPI objectives
- Collaborates with cross functional teams to drive timely releases
- Coordinates with distribution centers to manage blocked inventory
- Provides supporting documentation required for product registration in various countries
- Conducts training as needed on various Quality topics and supports the maintenance of training documents
- Participates in Internal and External Audits including Mock Recovery and Recall Exercises
- Manages signature files and CV documentation for the site
- Participates in On-Shelf Quality evaluations
- Participates in projects to drive Continuous Improvement initiatives
Requirements
- Bachelor's Degree
- Previous experience in a Quality role
- Technical writing proficiency
- Excellent written and oral communication skills
- Excellent organization skills and attention to detail
- High level of proficiency with MS Word and Excel
Preferred Qualifications
- Experience with SAP
- Bachelor’s Degree in Chemistry or Biology
- Experience in writing Nonconformances, Deviations, and CAPA(s)
- Experience writing Notes to File
- First-hand experience participating in regulatory inspections
- Experience in a manufacturing plant environment
- Experience working in a cGMP environment
- Experience reviewing product release documentation and final approval
- Knowledge of regulatory requirements as outlined by FDA, Health Canada, and other regulatory agencies
Qualifications
- Experience with SAP
- Bachelor’s Degree in Chemistry or Biology
- Experience in writing Nonconformances, Deviations, and CAPA(s)
- Experience writing Notes to File
- First-hand experience participating in regulatory inspections
- Experience in a manufacturing plant environment
- Experience working in a cGMP environment
- Experience reviewing product release documentation and final approval
- Knowledge of regulatory requirements as outlined by FDA, Health Canada, and other regulatory agencies
Benefits
- Salaried employees enjoy a comprehensive benefits package, including medical, dental, vision, basic life insurance, paid parental leave, disability coverage, and participation in the 401(k) retirement plan with company matching contributions subject to eligibility requirements.
- Additional benefits include a minimum of 15 vacation/PTO days (hourly employees receive a minimum of 120 hours) and 13 paid holidays (vacation days are prorated based on the employee's hire date within the calendar year).
- Paid sick leave is adjusted based on role and location in accordance with local laws.