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, Mennen, Softsoap, Irish Spring, Tom’s of Maine, Ajax, Fabuloso, Haci Sakir, elemex and Suavitel, as well as Hill’s Science Diet and Hill’s Prescription Diet.
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Our company invites applications for the position of Quality Compliance Specialist for our Morristown, TN new Oral Care Focus Factory Facility. The Compliance Specialist is responsible for the development, implementation of the focused site validation master plan, ensuring necessary change controls are documented and approved prior to execution of changes, support internal audit program, responsible for conducting positive product releases for Oral Care Focus focused facility, contract manufacturers and following up for Corrective and Preventative Actions, act as back up to Compliance supervisor for finished product releases for dental cream making facility as per necessary FDA Regulations for prescription products and medical devices. He or she must be able to deliver the agreed to business results while maintaining positive employee relations.
The initial accountability's of the role include developing the Master Validation Plan in alignment with Quality, Engineering, Operations and Planning teams, Change Control Activities for the new focused factory and developing site standard operating policies and procedures . The Compliance Specialist has to be an effective and valuable member of the Quality team, to ensure delivery of subsidiary business results in his or her area. The Compliance Specialist works within a structure that requires considerable interface with Making, Planning, Production, Warehousing and R&D.
Additional Responsibilities include:
- Developing new focus factory validation master plan, establishing realistic timeline for all validation activities for a new Oral Care Focus Factory start-up
- Lead / Support CAPA Program for the focused factory, Quality Training Initiatives and assist in conducting Internal audits and on shelf Quality Audits
- Validation Project organization approval of protocols including timeline development and follow up thereafter
- Communication of progress and issues to the team and Leadership
- Driving cross-functional Project Teams
- Scheduling and monitoring activities for Internal Audit, validation, SOP review
- Lead the plant wide change control program for new Oral Care Focused Factory Facility site
- Assuring validation activities meet all necessary Regulatory, Quality and Safety expectations
- Coordinate and lead Change Control Program for focused factory
- Positive 6 stream release of finished products for new focused factory and serve as back up to final releases for dental cream facility.
- Review all relevant data and conduct final release for all contract manufacture releases
- Validation Project Management:
- Understand the validation requirements for each specific application and provide technical direction to all team member
- Adapt Validation Master Plan requirements and obtain approvals to deviate from such when technical obstacles are encountered
- Develop, track, and communicate overall program KPI’s.
- Overall coordination of validation tasks, assignments and activities.
- Develop and maintain project time lines for all major validation initiatives
- Develop and implement sustainable Validation processes that become integrated in to the facilities work flow culture.
- Quality control
- Maintain necessary the quality compliance defined in project guidance documents even when short cutting may be perceived to be required to keep the project on schedule.
- Develop SOP, site policies and document templates in accordance with compliance with necessary 21 CFR and Part 820 medical device regulations so that consistency of quality is maintained throughout the project.
- Develop a tracking system for personnel assignments and report on a regular basis
- Catalog all relevant documentation for the new facility in storage areas.
- Document in approved reporting formats for all necessary validations
- Communication / Validation Project Management
- Bi- Monthly communication of project time lines and Change Control Program progress and escalate issues of anticipated hurdles to necessary parties
- Make sure team members understand their duties and schedules
- Meet on a regular basis to ensure follow up for validation activities and project
- Coordinate with engineering, operations, quality laboratory to schedule workflow to meet validation project objectives with minimum impact on manufacturing operations
- Coordinate with laboratory personnel to provide sufficient time to prepare for extra workload beyond their normal routine.
- Publish and update the schedule throughout the project, including plans to bring the project back on schedule.
- Monitor progress against plan and evaluate reasons for deviations and recommendations to bring back on track.
- Coordinate regular Change Control meeting to ensure Change Control expectations are met
- Bachelor’s Degree in Chemistry, Biology, Microbiology or Engineering (Chemical or Industrial)
- Minimum of 3 years work experience in Quality compliance for 21 CFR and 820 regulations with validation in pharmaceutical environment
- Ability to work irregular shifts, including nights, weekends or holidays as needed required
- A minimum of two years of experience using SPC, Minitab or other statistical tools
- Excellent knowledge of GMPs
- Experience in a regulated industry (i.e. FDA, EPA, OSHA, etc)
- Experience in a Technology Transfer role
- Experience using SAP or other plant related computer
- Proven ability to manage multiple priorities in a fast-paced environment
- Strong interpersonal and training skills
Equal Opportunity Employer
Colgate is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender identity, sexual orientation, national origin, ethnicity, age, disability, veteran status, marital status, or any other characteristic protected by law.