Quality Assurance - Specialist, Training

Location
College Station, TX
Posted
Jul 13, 2021
Ref
2021-15457
Hotbed
Lone Star Bio
Required Education
Bachelors Degree
Position Type
Full time

  The Quality Assurance (QA) Specialist for Training will be responsible for helping to deliver Quality Specific training for the department and the site. They will be responsible for delivery of onboarding training.

External US

Essential Functions:

  • Leadership
  • Act as an ambassador for FDBT Quality Culture.
  • Training
  • Support Quality and Site Wide Training Initiatives
  • Proactively identify training needs within Quality, proposing and implementing actions to address them.
  • Proactively identify training needs across the business, proposing and implementing actions to address them.
  • Clearly demonstrate training effectiveness.
  • Deliver Training for Trainers to ensure SMEs are competent to deliver training.
  • New Business Growth
  • Work with Quality management to implement effective training.
  • Work as a change agent to assist business in defining and addressing training needs.
  • Compliance
  • Deputize fronting site approach to Training in audits (as required).
  • Provide QA oversight for training materials produced across the business.
  • Design training packages and demonstrate effectiveness in the workplace.
  • All other duties as assigned.

Required Skills & Abilities:

  • Ability to convey knowledge and understanding in a manner that can be understood by all trainees.
  • 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.
  • Develop staff to maximize contributions to the team and the company.
  • 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 OR
  • At least 2 years of cGMP experience.

Preferred Qualifications:

  • Training Qualifications
  • Demonstrable experience of delivering training

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 979-431-3528.