Quality Assurance - Validations

Quality Assurance-Validations

Jost Chemical is seeking ambitious, hard-working talent for the Jost Quality Assurance Team!

Are you looking for a career at a fast-paced environment, where your hard work and dedication will pay off? Are you a team player, who sets goals to get the job done and would like to use your skills to grow with a great company?

Then, this position is right for you!

Quality Assurance-Validations

Position: Full time

Our offer:

• Medical/Dental/Vision Plan Insurance, Short and Long-Term Disability and Life Insurance after 60 days.
• 3% Safe Harbor contribution to your 401k.
• Up to a 4% Discretionary Match (like a profit-sharing contribution) to your 401k.
• Paid Time Off (PTO) Employees eligible after 90 days of continuous employment.
• 9 Company Paid Holidays (72 hours) each year.
• Uniforms Provided
• Foot Protection- annual allowance for all laboratory, maintenance and production employees.
• 24-hour access to our free, on-site fitness center.
• We provide Individual development, on-the-job training, and development programs designed to enhance your professional growth and development while ensuring you feel valued, inspired and appreciated at work.

Jost Chemical is an equal opportunity employer and affirmatively seeks diversity in its workforce. We consider applicants, and make all employment decisions, without regard to race, color, religion, creed, gender, national origin, age, disability, marital or veteran status, or any other legally protected status. We are committed to recruiting and retaining the best talent in the chemical manufacturing industry.

Education Requirements

• Bachelor of Science in Chemical Engineering or Chemistry preferred, Biochemistry or Biology acceptable

Knowledge & Experience Requirements

• Strong knowledge of GMP and FDA expectations
• Strong technical writing skills and understanding of complex processes and technical equipment
• Ability to work in a fast-paced environment while meeting productivity demands

Primary Responsibilities

• Administrator of Quality Management System software

  • Coordinating the development and maintenance of training curricula

  • Coordinating and developing testing to procedural based training

  • Assisting new users with system training and familiarity

  • Setting up roles and permissions with respective departments for their championing of procedures

  • Monitoring overall system suitability, updates, and validations thereof

  • Leading improvements utilizing QMS to improve compliance efficiencies and company objectives

• Validations for software as it relates to 21 CFR Part 11 compliance and Data Integrity

• GxP Assessments

• Risk Assessments for computerized systems GAMP5

• User Requirement Specification Development

• Electronic Records and Electronic Signatures assessments and implementation

• Component Impact Assessments and Implementation

• Installation, Operation, and Performance Qualifications (IOPQ) of instrumentation

• Assistance in IOPQ of other equipment and utilities as needed

• Standard Operating Procedure authoring and updating as needed

• Other QA functions as needed

Position Details

• Reports to QA Manager
• No direct reports
• First shift, full time, salaried position

Current Openings for Quality Assurance Validations Jobs at Jost Chemical Co.