Chemistry Lead Medical
1 week ago
Position Name: Quality Compliance Team Leader
Location : Sanford, ME
Monday - Friday
8:00am - 4:30pm or 5pm
Bachelor's Degree (or equivalent university degree) in Chemistry, Microbiology, Biochemistry, Engineering, or a related field
Travel Required up to 10% of time
Position Summary:
Client is a caring, innovative growth company that is reimagining a healthier future for all people, their pets and our planet. Focused on Oral Care, Personal Care, Home Care and Pet Nutrition, we sell our products in more than 200 countries and territories.
We are recognized for our leadership and innovation in promoting sustainability and community wellbeing, including our achievements in decreasing plastic waste, and promoting recyclability, saving water, conserving natural resources and improving children's oral health.
If you want to work for a company that lives by their values, then give your career a reason to smile and join our global team
Positive Release of Finished Goods is at the core of this position's daily responsibility.
A key role is to maintain a comprehensive site documentation system, author and maintain the site Validation Master Plan, and ensure site-wide compliance to 21 CFR Parts 11, 210, 211, and 820.
Responsibilities Include:
coaches and mentors site personnel in regard to Compliance issues.
Lead/participate in consumer/customer satisfaction improvement initiatives.
Support the development, implementation, and monitoring of the manufacturing site Quality Plan to ensure compliance with both GMP's and CP Global Quality Standards.
Responsible for daily documentation authorizing product release and the execution of release procedure.
Interpret and communicate regulatory policies and requirements to CP personnel (local resident expert and leader for compliance and related GMP concerns).
Supervision and management of plant Documentation system (This includes all documents vital to an FDA inspection- SOP's, Management of Change, Notices of Deviation, Batch Records, Non conformances, and Validations)
Supervise Consumer Complaint trends and history. Ensures that all returned samples and adverse event complaints are fully investigated and documented.
Manage the Site Annual Product Review and provide necessary compliance documentation and corrective action strategies for continuous improvement
Ensure that the designs, specifications, implementation, and maintenance of an cGMP system follows current regulations and CP standards
Supervision and management of site's Management of Change (MOC) program.
Supervision and management of FDA Drug Listings and international drug registrations.
Contribute to the local Automation, Digitization and Analytics (ADA) strategy, in specific with the paperless initiatives.
Ensures the development of people, teams, and organizational capabilities by empowering team members through training, information sharing, mentor, feedback, and delegation
Required Qualifications
Bachelor's Degree (or equivalent university degree) in Chemistry, Microbiology, Biochemistry, Engineering, or a related field.
5+ years' work experience in a manufacturing plant operating in a Food or Drug / GMP environment.
Comprehensive knowledge of site wide documentation system, Product Release, and Batch record review.
Must be familiar with and able to implement GMP compliant Failure Investigations, Corrective and Preventive Actions, and Notices of Deviation.
Knowledge of Change Control Systems and FDA regulations.
Leadership skills.
First-hand experience managing or supporting regulatory inspections.
Experience with SAP QM, LIMS, or similar integrated computerized systems.
Preferred Qualifications:
Supervisory experience.
Building and supporting strategic relationships and common programs with Product Development, Regulatory Affairs, Supply Chain Management, EOHS, and Global Materials, Logistics & Sourcing Departments, as well as material/component suppliers is also an expectation of this position.
2 years of experience preparing documentation for Product Registration in country of sale.
2 years of experience managing Consumer Complaints.
2 years of experience completing Product Release documentation and final approval.
Experience in hosting/leading an FDA inspection is highly desired.
Experience with utilization of statistical tools (e.g. MiniTab) is desired.
BENEFITS
Insurance: Employees (and their eligible dependents) are eligible to participate in Company-sponsored Medical, Dental, Vision, Basic Life Insurance, Accidental Death & Dismemberment and Disability insurance plans.
Retirement Plans: Employees are eligible to enroll in client's 401(k) plan, which provides for company matching contributions subject to eligibility requirements
Vacation/PTO: Employees receive a minimum of 15 days of vacation/PTO leave annually
Paid Holidays: Employees receive a minimum of 13 paid/floating holidays annually
Paid Sick Leave: Based on location and consistent with applicable state and local law, employees receive a minimum of 40 hours of paid sick leave on January 1st of each year
Paid Parental Leave: Eligible employees may take up to eight weeks of paid parental leave and 12 weeks of unpaid leave (varies for employees with fewer than 12 months of service and is subject to hours worked requirements)
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