Quality Assurance - Analyst II

Summary:

The Quality Assurance (QA) Analyst II, under general direction, will be responsible for review and/or approval of basic and technical documentation; Drafting and reviewing of internal Quality policies and procedures; Assisting in and performing product related activities; Assisting in and performing Quality audit functions; Identifying process and Quality System improvements; Acting as a QA liaison internally.

External US

Essential Functions:

• Review basic and technical documentation to include, but not limited to:
  • Standard Operating Procedures
  • Analytical Methods
  • Disposition certificates
  • Batch Production Records
  • Corrective Action/Preventive Action Plans
  • QC Data review
  • Technical Data Review
  • Drug Substance/Product Reports
• Review internal Quality policies, procedures and reports
• Assist in and perform Quality audit functions to include, but not limited to:
  • Audit of lab notebooks
  • Audit of equipment logbooks
• Act as a QA liaison to internal Departments and Vendor/Contract Laboratory Quality Groups
• Notify Supervisor of potential quality or regulatory issues that may affect product quality or regulatory compliance
• All other duties as needed.

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 adapt to frequent and rapid changes in the work environment and allocate, adjust and optimize time accordingly
• Ability to work independently and establish work priorities to meet targets and timelines
• Proficient in Microsoft Excel, Word and PowerPoint

• All candidates will 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 sitting, 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 with this position.
• 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.
• Lifting up to 25 pounds on occasion.
• Ability to wear restrictive gowning for extended periods of time during periods of prolonged standing.

Management and GMP experience may be evaluated in candidate with less years of Pharmaceutical / Regulated Industry experience.

• Attendance is mandatory.

Qualifications:

High School or equivalent:  6 years or more of Pharmaceutical or other Regulated Industry experience.

Associates Degree: 4 years or more of Pharmaceutical or other Regulated Industry experience.

Bachelor's Degree:  2 years or more of Pharmaceutical or other Regulated Industry experience.

Master's Degree:  1 year or more of Pharmaceutical or other Regulated Industry experience.

Preferred Qualifications:

• ASQ Certification
• Degree in Biology or Chemistry

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.