Facilities Management (FM) Quality /Compliance Staff Engineer

Johnson & Johnson Innovative Medicine • Jacksonville, FL

1d • Onsite

About The Position

The Facilities Management (FM) Quality /Compliance Staff Engineer provides support and direction to the Facilities department in respect of specific quality system elements to ensure business, quality and compliance goals are met following the J&J Standard of Leadership behavior model. Partners with other Departments and contractors to ensure that compliance systems are implemented in an efficient manner.

Requirements

• Bachelors or equivalent university degree in a Scientific/Technical subject area is required.
• A minimum of 4 years of related work experience.
• Experience in a quality, manufacturing, validation or compliance role within a GMP regulated industry.
• Knowledgeable of FDA/EMEA regulatory requirements applicable to Medical Device and/or pharmaceuticals.
• Ability to apply GMP regulations and other FDA and international guidelines to all aspects of the position.

Nice To Haves

• Experience in auditing of external suppliers, contractors and vendors.
• Experience in development/and or evolution of GMP systems and/or start up experience is highly desirable.
• Experience in a quality, manufacturing, validation or compliance role within the Medical Device and/or pharmaceutical industry.
• General knowledge of Facility support services including: GMP cleaning, cafeteria regulatory compliance, pest control, audit readiness, critical to quality preventative maintenance.

Responsibilities

• Supports the development and management of GMP compliance systems through the following activities:
• Carries out tasks related to the administration of site nonconformance management systems: Reviews and/or approves nonconformance investigations and their associated documentation.
• Manages entry of nonconformance records into the appropriate electronic system.
• Tracks investigations from the initiation through closure processes and advises relevant personnel on the status of investigations and associated CAPA and commitments, as appropriate.
• Coordinates investigation activities to ensure root causes are identified and that corrective actions are appropriate.
• Approves closure of nonconformance investigations on completion of the investigation and associated corrective actions.
• Supports the development and management of document management systems which can include: Administration of the Electronic Document Management Systems at the site
• Develops and applies systems and procedures related to the Electronic Document management System at the site
• Carries out tasks related to the management of document control in respect of SOPs and other GMP regulated documents
• Supports and advises Documentation Control administration personnel, as the need arises
• Provides training and support to users.
• Generates reports and metrics from the system as the need arises.

Benefits

• We provide an inclusive work environment where each person is considered as an individual.
• At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager