Documentation Specialist

No Relocation Assistance Offered
# 154596 - Hodges, South Carolina, United States

The Documentation Specialist will manage and organize all Quality Documentation that is required by Colgate-Palmolive (Greenwood, SC facility). This will include issuing, maintaining, controlling, and auditing documentation that is required for Quality and cGMP compliance. Batch Record Review and gathering documents required for product release is also a major role.

Responsibilities include:

• 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
• Responsible for the review and maintenance of 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
• Ensure the release process is completed in timely manner. Reducing the Product Release Time (PRT)
• Coordinates with distribution centers to manage blocked inventory
• Responsible for the creation and distribution of COAs for exports
• 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
• Support releases during the weekend.
• Perform the collection of documents and completion of Compliance Documentation such as Compliance Binder and Regulatories Support Documentation.

Qualifications Required

• Bachelor's Degree
• 1 year in Previous experience in a Quality role, working directly with Quality Systems.
• Technical writing proficiency
• Excellent written and oral communication skills
• Excellent organization skills and attention to detail
• High level of proficiency with MS Word, Excel and Google Sheets.
• High level of proficiency with Data Analytics.

Preferred

• Experience with SAP
• Bachelor’s Degree in Chemistry or Biology
• Experience in writing Nonconformances, Deviations, and CAPA(s)
• Experience writing Notes to File
• Experience as an auditor
• 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
• Direct Experience and Knowledge of regulatory requirements as outlined by FDA, Health Canada, and other regulatory agencies.

Salary Range $64,000-80,000 USD

Equal Opportunity Employer
Colgate is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, ethnicity, age, disability, marital status, veteran status (United States positions), or any other characteristic protected by law.

Are you interested in working for Colgate-Palmolive? You can apply online and attach all relevant documents such as a cover letter and resume or CV. Applications received by e-mail are not considered in the selection process. Become part of our team. We look forward to your application.

Colgate-Palmolive is a leading global consumer products company, tightly focused on Oral Care, Personal Care, Home Care and Pet Nutrition. Colgate sells its products in over 200 countries and territories around the world under such internationally recognized brand names as Colgate, Palmolive, elmex, Tom’s of Maine, Sorriso, Speed Stick, Lady Speed Stick, Softsoap, Irish Spring, Protex, Sanex, Elta MD, PCA Skin, Ajax, Axion, Fabuloso, Soupline and Suavitel, as well as Hill’s Science Diet and Hill’s Prescription Diet.

For more information about Colgate’s global business, visit the Company’s web site at http://www.colgatepalmolive.com. To learn more about Colgate Bright Smiles, Bright Futures® oral health education program, please visit http://www.colgatebsbf.com. To learn more about Hill's and the Hill’s Food, Shelter & Love program please visit http://www.hillspet.com. To learn more about Tom’s of Maine please visit http://www.tomsofmaine.com.

Reasonable accommodation during the application process is available for persons with disabilities. Please contact Application_Accommodation@colpal.com with the subject "Accommodation Request" should you require accommodation.