Quality Engineering Specialist
This is a direct hire position
PinPoint Solutions is hiring a Quality Engineering Specialist
The Quality Engineering Specialist is responsible for performing technical functions in the Quality Assurance Department. Primary functions will be client liaison, investigating non-conformances, performing risk assessments, reviewing protocols and reports, trend evaluation and reporting, technical review of critical procedures and processes, coordinate process changes and new product introduction, assist with regulatory and client responses, and develop and implement process improvements.
- Will be a direct client liaison assigned the responsibility for specific project related QA product/client relations and support.
- Will be liaison between Quality Assurance and other departments to ensure Quality Assurance commitments are completed. They will operate in a cohesive fashion.
- Required to work both independently and with other departmental or non-departmental personnel.
- Investigation and writing of non-conformances such as deviations, complaints, OOS, OOT, deviations, etc.
- Reviewing process, product and equipment related validation and stability protocols and reports
- Performing risk assessments and gap analysis
- Trend evaluation and reporting
- Technical review of critical SOPs and processes
- Coordinate and work with Project Managers and Technical Transfer personnel on process changes and new product introduction
- Review client regulatory annual product reviews
- Developing and implementing process improvements
- Participates in Quality Assurance Process Improvement Teams
- Participates in client audits and regulatory inspections as needed
- Other assigned responsibilities as established by Manager.
- BS or BA degree in Science or Engineering with 5-10 years of GMP experience.
- Excellent writing and verbal ability.
- Experience with investigation and writing non-conformances (deviations, investigations, OOS, complaints, etc.) required.
- Ability to analyze data using statistical tools
- Must be able to independently lead a team in root cause analysis and solutions implementation.
- Willingness and ability to interact with all levels of personnel within the department and outside the department. A large portion of this activity will be solution-seeking efforts and root cause analysis.
- Willingness and ability to represent company at all management levels and with the clients.
- Knowledge of CGMP, EU Regulations, ISO, etc.
- Must have strong attention to detail.
- Must have ability to work independently.
- Ability to manage multiple priorities and tasks in a dynamic environment
- Strong process reviews and auditing capabilities
- Excellent written and verbal skills
- Ability to exercise judgment to determine appropriate corrective actions
- Ability to exercise judgment for defined practices and policies in selecting methods and techniques for obtaining solutions
- Ability to use computer programs
- Ability to work in a team and individual environment
- Ability to present the outcome of investigations on non-conformances to management and/or client using visual tools such as PowerPoint and Visio.
HKA Enterprises is a global workforce solutions firm. If you're seeking a new career opportunity or project experience, our recruiters will work to understand your qualifications, experience, and personal goals. At HKA, we recognize the importance of matching employee goals with those of the employer. We strive to seek credibility, satisfaction, and endorsement from all of our applicants. We invite you to take time and search for your next career experience with us! HKA is an EEO Employer who participates in the US Citizenship and Immigration Services E-Verify Program.