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Quality Assurance Specialist II, Supplier Quality
2 months ago
The Quality Assurance (QA) Compliance Analyst II, Supplier Quality will play a critical role in supporting the supplier quality program at FUJIFILM Corporation. This position will be responsible for ensuring all suppliers of raw materials, consumables, and GMP services are qualified prior to use within the facility.
Key Responsibilities- Compliance: Ensure compliance with cGMP regulations and company policies.
- QA Representative: Serve as the QA representative to external suppliers, ensuring their quality systems meet company standards.
- Internal Audits: Support the organization in conducting internal audits and hosting audits/inspections.
- Supplier Quality System: Interface and coordinate with sister sites on supplier quality system, harmonization, and joint qualification.
- Approved Supplier List: Maintain the approved supplier list, ensuring only qualified suppliers are used.
- Complaint Handling: Process and track complaints to suppliers, ensuring timely resolution.
- Reporting: Develop and issue weekly and monthly metric reporting on supplier performance.
- Audit Support: Provide audit support when needed, ensuring compliance with company policies and regulations.
- Material Review Board: Participate in the Material Review Board (MRB) review of nonconforming product, recommending disposition and corrective action.
- Education: Master's degree in a science-related field with 1 year of cGMP experience supporting pharmaceutical or biotechnology products; OR Bachelor's degree in a science-related field with 2 years of cGMP experience supporting pharmaceutical or biotechnology products; OR Associates degree with 4 years of cGMP experience supporting pharmaceutical or biotechnology products.
- Skills: Excellent written and oral communication skills, excellent organizational, analytical, data review and report writing skills, ability to set personal performance goals and provide input to departmental objectives, ability to multitask and easily prioritize work, ability to work independently with little supervision, proficient in Microsoft Excel, Word and PowerPoint.
- Preferred Qualifications: Degree in Biology, Chemistry or Engineering, Six Sigma Green/Black Belt cGMP experience, ASQ Quality Auditor Certification, cGMP experience.
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.
- Prolonged standing, some bending, stooping, and stretching.
- Ability to sit for long periods to work on a computer.
- Potential for exposure to chemicals, 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.
- Must be willing to work flexible hours.
- Ability to work weekends and off-shift hours, as needed to support manufacturing activities.
- Must be willing to travel occasionally, as needed.
- Attendance is mandatory.
