Quality Assurance Specialist II, Supplier Quality
3 weeks ago
The Quality Assurance Specialist II, Supplier Quality will be responsible for supporting the supplier quality program. This role will assist with ensuring all suppliers of raw materials, consumables, and GMP services are qualified prior to use within the facility.
Key Responsibilities- Compliance: QA representative to external suppliers, support to the organization in conducting internal audits and hosting audits/inspections, interface and coordinate with sister sites on supplier quality system, harmonization, and joint qualification, maintain approved supplier list, process/track complaints to suppliers, develop and issue weekly and monthly metric reporting on supplier performance, provide audit support when needed, participate in Material Review Board (MRB) review of nonconforming product; recommend disposition and corrective action.
- Leadership: Work collaboratively with site management to instill a 'Quality Culture' by coaching in applying GMP Principles including the underlying rationale of those principles.
- New Business Growth: Support client due diligence and Quality audits as well as regulatory inspections, work with Quality management to implement and grow phase-appropriate quality systems that will enable cGMP manufacturing of pre-clinical to commercial products, supplier complaint handling, change notification management and specification quality assurance approval, serve as Subject Matter Expert for various SQA functions.
- 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.
- All candidates must have a working knowledge of cGMP regulations for the production of drug, biologics or vaccine products.
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 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 is required.
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.
Qualifications- 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.
Preferred Qualifications: Degree in Biology, Chemistry or Engineering, Six Sigma Green/Black Belt, cGMP experience, ASQ Quality Auditor Certification.
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College Station, Texas, United States FUJIFILM Holdings America Corporation Full timeJob SummaryThe Quality Assurance Specialist II, Supplier Quality will play a critical role in supporting the supplier quality program at FUJIFILM Holdings America 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...
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College Station, Texas, United States FUJIFILM Corporation Full timeJob SummaryThe Quality Assurance (QA) Compliance Analyst II, Supplier Quality will be responsible for supporting the supplier quality program. The SQA Specialist II will assist with ensuring all suppliers of raw materials, consumables, and GMP services are qualified prior to use within the facility.Key ResponsibilitiesCompliance: QA representative to...
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College Station, Texas, United States FUJIFILM Corporation Full timeJob SummaryThe Quality Assurance Specialist II, Supplier Quality will be responsible for supporting the supplier quality program. This role will assist with ensuring all suppliers of raw materials, consumables, and GMP services are qualified prior to use within the facility.Key ResponsibilitiesCompliance: Represent the company in external audits and...
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