Quality Assurance - Environmental Monitoring Specialist

Summary:  The Quality Assurance Environmental Monitoring Specialist will be responsible for supporting the EM program, review and approval of EM investigations, proactive trend identification of EM trends, supporting the conceptualization / implementation / and effectiveness checks of corrective or preventative actions as it pertains to the sites EM program.

External US

Essential Functions:

• Leadership
  • The Quality Assurance EM Specialist shall have oversight of one or more of the following areas:
    • Deviation Management
    • Batch Impact as a result of trend analysis or over alert / action EM levels
  • Demonstrates ability to problem solve and effectively communicate quality issues across multiple functions.
  • Aid in the development of EM investigators and the sites EM culture.
  • Support EMPQ Discrepancy Investigations
  • Approval of periodic trend reports
  • Support / Enhance Contamination Control Strategy
• Operational Delivery
  • Ensure appropriate tracking and timely resolution of quality issues (Deviations, Corrective/Preventive Actions and Change Controls).
  • Ensure Appropriate Organization and Control of In Process Documentation
  • Timely review / approval of basic and technical documentation to include, but not limited to:
    • Standard Operating Procedures
    • Work Instructions
    • QC data review and approval
  • Compliance
    • Ensure self has no overdue training, or site actions. Support other QA teams and other functions in completion of site actions.
    • Continuously improve the processes specified in Standard Operating Procedures and Work Instructions operated by self and direct reports whilst still ensuring the operations meet all current regulatory requirements.
    • Provide GMP guidance to other site departments such as Manufacturing, Facilities, and QC
    • Prompt notification of Management of potential quality or regulatory issues that may affect product quality or regulatory compliance.
  • All other duties as assigned.

Required Skills & Abilities:

• Apply knowledge of and adhere to cGMPs, company Quality Policies and site SOPs on a daily basis, as applicable.
• Excellent written and oral communication skills.
• Excellent organization, detail oriented and accurate.
• Self-motivated with a drive for excellence.
• Positive attitude and strong interpersonal skills.
• Creative independent thinking and can work with minimal supervision following internal procedures .
• Resilient through operational and organizational change.
• Exceptional planning and organizational skills and the ability to multi-task and meet deadlines is required
• Proven effective teamwork skills: able to adapt to diverse interpersonal styles.
• Develop staff to maximize contributions to the team and the company.
• Interacts with all departmental staff, including giving training and / or presentations to small and large groups.
• Proficient with Microsoft Office products (Excel, Word, and PowerPoint).

Preferred Experience, Behavioral Competencies, Skills & Abilities:

• Excellent presentation skills. Author and/or update standard operating procedures, work instructions, or policies.
• Experience with Google Sheets, SmartSheets, and Microsoft SharePoint
• Experience with the following applications: Trackwise, MasterControl, ComplianceWire, SAP, Blue Mountain Regulatory Asset Manager (BMRAM), MODA, Delta V.

Working Conditions & Physical Requirements:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.  While performing the duties of this job, the employee is regularly required to:

• Experience prolonged standing, some bending, stooping, and stretching
• Ability to sit for long periods to work on a computer

• Potential for exposure to chemical, gases, fumes, odors, dusts, and other hazardous materials.
• Ability to wear personal protective equipment including but not limited to safety glasses, lab coat, gloves, specialized clothing including laboratory scrubs (pants and shirt), cleanroom (ISO 8 to ISO 5) gowning material and appropriate shoes required in most areas associated with this position.
• Lifting up to 25 pounds on occasion.
• Use hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment is required.
• Must be willing to work flexible hours
  • Ability to work weekends and off-shift hours, as needed to support manufacturing activities.
  • Attendance is mandatory

Qualifications:

• Bachelors Degree with 4 or more years in a regulated industry.
• Minimum 2 years GMP experience.
• Minimum 2 years with a focus on Environmental Monitoring support or management

Preferred Qualifications:

• Certified Quality Auditor
• Degree in Biology or Chemistry

We are an equal opportunity and affirmative action employer.  All qualified applicants will receive consideration without regard to race, color, national origin, sex, gender identity, sexual orientation, religion, disability, protected veteran status or any other characteristic protected by applicable federal, state, or local law. 

If an accommodation to the application process is needed, please e-mail FDBTHR@fujifilm.com or call 979-431-3500.