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COMPLIANCE SUPERVISOR--FOOD/DRUG/cGMP MANUFACTURING

PORTLAND, ME
POSITION TITLE--COMPLIANCE SUPERVISOR--FOOD/DRUG/cGMP MANUFACTURING
 
SALARY-OPEN-OUR CLIENT PREFERS WE DON'T POST SALARY INFO PUBLICLY BUT IF INTERESTED PLEASE APPLY AND WE WILL SHARE SALARY INFO DIRECTLY WITH YOU
 
LOCATION--PORTLAND, ME
 
 
THE OPPORTUNITY:

The Compliance Supervisor is responsible for developing, implementing and monitoring the manufacturing site's quality systems and regulatory compliance. This responsibility directs conformance to the GMP/Quality standards and establishes a culture to enable the site to deliver consistent, safe and effective products. Positive Release of Finished product is at the core of this position's daily responsibility. A key role is to maintain a comprehensive site documentation system. The Compliance Supervisor coaches and mentors site personnel in regards to Compliance issues. This position will lead/participate in consumer/customer satisfaction improvement initiatives. Building and supporting strategic relationships and common programs with Product Development, Regulatory Affairs, Supply Chain Management, EOHS,and Stewardship Council, as well as material/component suppliers is also an expectation of this position.


 
Responsibilities include:

    Support the development, implementation and monitoring of the site’s Quality Plan to ensure compliance with both cGMP'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 personnel (local resident expert and leader for compliance and related cGMP concerns). Provide input for regulatory compliance requirements to the site team as needed.
    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, Nonconformance, and Validations).
    Monitor Consumer Complaint trends and history. Ensures that all returned samples and adverse event complaints are fully investigated and documented.
    Manage & coordinate 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 a cGMP system follows current industry practices and procedures.
    Manage Internal Audit program and follow up items to closure.
    Lead failure investigations and manage the CAPA program; to include documentation of closure and CAPA effectiveness evaluation.
    Responsible for Management of Change Program and Change Control Database.
    Responsible for product registrations for Regulatory Agencies.

 
Basic Qualifications:
Required:

    Bachelor's degree in Chemistry, Microbiology, Engineering, Biology or Business.
    5 years minimum work experience in a Food or Drug / cGMP environment.
    Must be familiar with and able to execute GMP compliant Failure Investigations, Corrective and Preventive Action ,Notices of Deviation, and Management of Change documentation
    First hand experience managing FDA regulatory inspections.
    Excellent communication and organizational skills.
    Extreme attention to detail and accuracy.
    The ability to set priorities and perform several tasks within a prescribed time frame. Time management and ability to work under pressure.
    Ability to work independently with initiative.

 
Preferred:

    Experience in a manufacturing plant environment
    Experience preparing documentation for Product Registration in country of sale
    Experience managing Consumer Complaints
    Supervision experience
    Experience completing Product Release documentation and final approval
KP RECRUITING GROUP
 
KP Recruiting Group was started to create a world-wide network of multi-level, highly skilled talent; that are either experts or working to become one, in their respective fields. Our process involves focusing on the talent, skills, and experience of an individual as a key indicator of the present and future value that they will bring to any organization.

In establishing a network, we are able to forge genuine relationships with talent and gain valuable insight that allows us to understand what motivates them. This data allows us to give strategic advice to our partners as they go through the process of managing their human capital.

See our jobs and apply here: https://kprecruitinggroup.catsone.com/careers/7781-General

 
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