Quality Assurance - Compliance Specialist II

  The Quality Assurance (QA) Specialist of compliance, will be responsible for supporting performance of the Quality Systems group.  The Specialist will assist with the tracking and coordination and closure Change Control records.

External US

Essential Functions

 

Compliance Delivery

• Support to the organization in coordinating and closing Change Controls, to be on-time
• Develop and issue weekly and monthly metric reporting

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.
• Support client audit requests

Compliance

• Ensure self, and team, have no overdue training, or site actions. Support other QA teams and other functions in completion of site actions.
• Provide cGMP assistance to other functions such as Manufacturing, Facilities and QC.
• Promptly notify Senior Management of potential quality or regulatory issues that may affect product quality or regulatory compliance.
• All other duties as assigned.

Required Skills & Abilities

• 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.

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 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

• Bachelor's degree in a related science concentration with 2 years of experience of cGMP supporting pharmaceutical or biotechnology products; OR 1 year experience with FDB with a related role.
• Associate's degree in a related science concentration with 4 years of experience in a regulated industry, including 2 years of experience of cGMP supporting pharmaceutical or biotechnology products; OR
• High School or equivalent 6 years or more of Pharmaceutical or other Regulated Industry experience.

Preferred Qualifications

• Degree in Biology, Chemistry or Engineering

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 email FDBTHR@fujifilm.com or call 979-431-3528.