QA Analyst I - All Shifts

Fujifilm; College Station (TX); On-site; USD 50,000 - 70,000; Full time

Job summary

Fujifilm in College Station, TX, seeks a QA Analyst I to assist in the review of technical documentation and quality audits. Candidates must hold a Bachelor’s degree in science or possess relevant experience in regulatory environments.

The ideal applicant will excel in written and oral communication, be organized, and have a strong knowledge of GMP/GLP regulations, with a commitment to the organization’s core values. Proficiency in Microsoft Office is required.

Qualifications

• Bachelor's degree in a related science concentration required.
• Associate's degree with 2+ years of experience in a regulated industry.
• High School Diploma with 4+ years of experience in a regulated industry required.

Responsibilities

• Assist with review of basic documentation.
• Assist in Quality audits.
• Notify Senior Management of potential quality issues.

Skills

Excellent written and oral communication skills

Excellent organizational skills

Data review and report writing skills

Ability to adapt to changes

Proficient in Microsoft Office

Education

Bachelor’s degree in a related science concentration

Associate’s degree in a related science concentration with 2+ years of experience

High School Diploma or GED with 4+ years of experience

Job description

Position Overview

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

Job Description

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.

Qualifications:

• Bachelor’s degree in a related science concentration with some experience in pharmaceutical or other regulated industry; OR
• Associate’s degree in a related science concentration with 2+ years of experience in pharmaceutical or other regulated industry; OR
• High School Diploma or GED with 4+ years of experience in pharmaceutical or other regulated industry 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.

EEO Information

Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc.

ADA Information

If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department ([e-mail] or [phone]).