Quality Assurance - Investigator l

Quality Assurance-Investigator I

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-Investigator I

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.
• 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.

Quality Assurance- Investigator I

Education Requirements

• Bachelor of Science in Chemical Engineering, Chemistry, Biochemistry or related field

Knowledge & Experience Requirements

• 3+ years working in a regulated pharmaceutical/chemical manufacturing environment
• 1-3 years direct experience in conducting investigations, root cause analysis, and execution of CAPAs in an FDA regulated environment
• Familiar with root cause analysis and utilization of investigation tools and methods
• Strong critical thinking, analytical thinking, deductive reasoning, and problem-solving skills
• Knowledge of GMP, ICH, pharmaceutical compendia and FDA expectations
• Strong technical writing skills and understanding of complex and complicated issues
• Ability to work in a fast-paced environment while meeting productivity demands
• Ability to present on issues, trends, and similar events with clear, concise, technical language
• Proficient in various software programs (Word, Excel, eQMS...)

Primary Responsibilities

• Initiate, track, trend, lead, write, and close all investigations into internal failures and external customer complaints
• Drive completion of all corrective and preventive actions in a timely manner
• Assist department specific subject matter experts in root cause analysis
• Regularly conduct personnel interviews to learn sequence of events in root cause determination
• Review test data for chemical analyses as inherent part of investigations
• Develop investigation SOPs, work instructions, and conduct associated training
• Ensure proper verification of effectiveness for all corrective and preventive actions
• Maintain the corrective and preventive actions database and analyze trends
• Work with all aspects of operations (Production, Packaging, Project Engineering, Quality Assurance, Quality Control, Maintenance...) to ensure timely completion of CAPAs
• Ability to escalate actions cross-functionally when deadlines are approaching
• Participate in daily quality meetings to speak on status of issues and bring awareness to / resolve any developing trends
• Participate in cross functional meetings relating to failures
• Assist with creating weekly reports on all open investigations and ensure timely completion of investigations
• Assist with creating monthly reports on failure metrics and trends

Position Details

• Reports to QA Compliance Supervisor
• First shift, full time, salaried position

FLSA

• Exempt

Current Openings for Quality Assurance Investigator l Jobs at Jost Chemical Co.