Work closely with QC Managers and Quality Assurance to ensure all QC deviations and CAPAs are written appropriately and contain all relevant information required to meet department, company, and regulatory requirements.
- Work collaboratively with site management to instill a ‘Quality Culture’ by coaching Quality Control staff in the application of GMP Principles including the underlying rational of those principles.
- Responsible for leading OOS / OOT investigations, assist in authoring hypothesis and retest plans.
- Support the Quality organization during compliance and Due-Diligence audits, assist in preparing audit responses and ensure responses are actions are implemented within the given time frame.
- Support the internal Audit Programs to ensure the QC Department is in a state of compliance
- Work with Quality management to implement and strengthen Quality Systems that will enable cGMP release and stability testing of pre-clinical to commercial products
- Responsible for QC audit preparations, to include but not limited to: log book review, training record review, compliance wire review. Assist QC managers conducting internal Departmental audits. Coordinates the initiation of new deviations.
- Initiate and leads deviation, CAPA, and change control closure for Quality Control
- Leads Root Cause Analysis Investigations
- Attend customer meetings to provide investigational updates as needed.
- Establish and maintain metrics around deviations, CAPA’s and change control status.
- Assist QC Managers in reviewing protocols, reports, testing data and SOPs as needed.
- All other duties assigned
Required Skills & Abilities:
- Excellent oral and written communication skills, interpersonal and organizational skills.
- Excellent organizational, analytical, data review and report writing skills
- Proficient with Microsoft Office applications.
- Good self-discipline and attention to detail.
- Ability to multitask and easily prioritize work.
- Ability to work independently with little supervision.
- Must have good planning skills and must be willing to interface with and support team members in many different roles and functions throughout the manufacturing facilities.
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, pushing, pulling, reaching above shoulders and stretching.
- Use hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment.
- Lift up to 25 pounds frequently and up to 50 pounds, on occasion.
- Attendance is mandatory.
- Bachelor’s Degree with a minimum of 5 years working in a GMP environment
- Experience authoring CAPAs, change controls, and deviations
- Experience working in a Quality Assurance role, batch record review, analytical data review,
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.