Quality Assurance - Investigator lI

Quality Assurance-Investigator II

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 II

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 first day of 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 II

Background

• Works under general supervision of the Quality Assurance Compliance Supervisor in a cGMP regulated manufacturing environment operating under ICH Q7A standards.
• Employees in positions at this level perform tasks and duties associated with implementation of and compliance to quality assurance standards set by the organization and its customers with an intermediate competence level working on medium complexity investigations.

Tasks

• 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.
• Assist with training QA Investigators at lower levels.
• Other duties as assigned.

Specifications

• Bachelor of Science in Chemical Engineering, Chemistry, Biochemistry or related field
• 3+ years working in a regulated pharmaceutical/chemical manufacturing environment preferred.
• Minimum 2-3 years direct experience in conducting investigations, root cause analysis, and execution of CAPAs in an FDA regulated environment.
• Knowledge of:
  • cGMP regulations, ICH, pharmaceutical compendia and FDA expectations.
  • Root cause analysis and utilization of investigation tools and methods.
  • Basic Mathematics
  • MS Office software package (Broad level)
• Skill in:
  • Strong critical thinking, analytical thinking, deductive reasoning, and problem-solving skills.
  • Strong technical writing skills and understanding of complex and complicated issues.
  • Data Processing with attention to detail and documentation.
  • Working effectively and efficiently on multiple projects at once.
  • Working effectively in a team environment.
  • Responding to rapidly changing demands.
• Ability to:
  • Communicate effectively, orally and in writing.
  • Review, compile and verify technical data and documents.
  • Identify, gather, process and record data accurately.
  • Follow customer, organizational and regulatory standards.
  • Work in a fast-paced environment while meeting productivity demands.
  • Present on issues, trends, and similar events with clear, concise, technical language.

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