QA Analyst I - All Shifts

at  Fujifilm

THE WORK WE DO AT FDB HAS NEVER BEEN MORE IMPORTANT—AND WE ARE LOOKING FOR TALENTED CANDIDATES TO JOIN US. WE ARE GROWING OUR LOCATIONS, OUR CAPABILITIES, AND OUR TEAMS, AND LOOKING FOR PASSIONATE, MISSION-DRIVEN PEOPLE LIKE YOU WHO WANT TO MAKE A REAL DIFFERENCE IN PEOPLE’S LIVES. JOIN FDB AND HELP CREATE THE NEXT VACCINE, CURE, OR GENE THERAPY IN PARTNERSHIP WITH SOME OF THE MOST INNOVATIVE BIOPHARMA COMPANIES ACROSS THE GLOBE. WE ARE PROUD TO CULTIVATE A CULTURE THAT WILL FUEL YOUR PASSION, ENERGY AND DRIVE - WHAT FDB CALL GENKI.

External US:
College Station, Texas may be a small, university town, but the lively cultural scene and local amenities make it a great place for families as well as those who want the ease of small-town life and the convenience of living close to the vibrant pulse of big cities. Eighty-seven percent of Texas’ population lives within a 180-mile radius, so we are in the center of it all in Texas. And our site is nestled in the hub of innovation, representing a source of pride for the area.
The Quality Assurance (QA) Analyst I, under direct supervision, will be responsible for assisting with the review and/or approval of basic and technical documentation; Drafting and reviewing of internal Quality policies and procedures; Assisting with product related activities; Assisting with Quality audit functions; Identifying process and Quality System improvements.
Reports to Supervisor/Manager, QA
Work Location College Station, TX

QUALIFICATIONS:

• Bachelor’s degree in a related science concentration with some experience in Quality Assurance supporting pharmaceutical or biotechnology products; OR
• Associate’s degree in a related science concentration with 2+ years of experience in Quality Assurance supporting pharmaceutical or biotechnology products; OR
• High School Diploma or GED with 4+ years of experience in Quality Assurance supporting pharmaceutical or biotechnology products required.
• ASQ Certification preferred.
• Knowledge of GMP/GLP regulations preferred.
• 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 Office.
• All candidates will have a working knowledge of cGMP regulations to produce drug, biologics, or vaccine products.
• Role model for company core values of trust, delighting our customers, Gemba, and Genki.

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.
• Use hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment is required.
• Lifting up to 25 pounds on occasion.
• Ability to wear restrictive gowning for extended periods of time during periods of prolonged standing.
• Attendance is mandatory.

PRIMARY RESPONSIBILITIES:

• Assist with review of basic documentation to include, but not limited to:
• Standard Operating Procedures
• Corrective Action/Preventive Action Plans
• Data Reports
• Assist with review of internal quality policies, procedures, and reports.
• Assist with inspection of final product containers and review and/or approval of executed process records and data.
• Assist in Quality audits to include, but not limited to:
• Audit of lab notebooks
• Audit of equipment logbooks
• Review of vendor, supplier, contract laboratory audit questionnaires
• Notify Senior Management of potential quality or regulatory issues that may affect product quality or regulatory compliance.
• All other duties as needed.

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.
• Use hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment is required.
• Lifting up to 25 pounds on occasion.
• Ability to wear restrictive gowning for extended periods of time during periods of prolonged standing.
• Attendance is mandatory