Quality Assurance Specialist II

Quality Assurance Specialist II

The Quality Assurance Specialist is responsible for performing Quality Assurance (QA) functions to build, uphold, and improve the Company's Quality Systems. This position will work onsite, Monday – Friday from approximately 6:30 am – 3:00 pm.

This is what you will do:

• Support the Quality System infrastructure by performing QA tasks pertaining to the documentation of processes.
• Perform Good Manufacturing Practices (GMP) compliance tasks, including audits, and documentation maintenance.
• Perform internal supplemental audits to verify that facility records files are in conformance to applicable Standard Operating Procedures (SOP) and GMP regulatory requirements.
• Perform training and manage the Quality System's Training Program.
• Ensure documentation systems used in QA are properly maintained (e.g., QA audit records, training records).
• Perform protocol, data, and report inspections to verify conformance to applicable SOPs and GMP regulatory requirements.
• Evaluate responses to Incident reports and perform follow-up with respondents, or others, if needed, to ensure resolution.
• Make changes to SOPs, policies, training materials, and other documents in the records management system.
• Assist during regulatory inspections.
• Interface with various Divisions in problem resolution, and continual improvement.
• Support manufacturing failure investigations and define investigational strategy.
• Facilitate meetings.
• Apply discretion in decision-making.
• Demonstrate independent judgment and make recommendations regarding business practices.
• Formulate, implement, interpret, and affect policies and operating practices.
• Communicate effectively with others.
• Perform work onsite.
• Perform other duties as assigned.
• Perform at an experienced and functional level therefore requiring limited supervision.
• Engage in Professional Development Activities.

This is what you will need:

• BS/AAS degree desired, preferably in Chemistry or in physical or biological science – or equivalent industry experience
• Minimum 3 years' experience in a Food and Drug Administration (FDA) regulated manufacturing environment.
• Minimum 1-year experience training in a business setting.
• Minimum 3 years of progressive experience in Quality Assurance.
• Demonstratable strong written and verbal communication skills.
• Excellent organizational skills.
• Proven record of excellent documentation skills.
• Strong problem-solving skills.
• Work well under pressure and able to prioritize workloads.
• Ability to perform risk assessment.
• Experience fostering teamwork to get results.
• Well organized and multi-task oriented.
• Ability to work independently on multiple projects.
• Ability to read, write, and speak English competently.
• Ability to maintain reliable and predictable attendance.
• Worked in pharmaceutical, nutraceutical or similar mfg. environment (preferred).
• American Society for Quality certifications (preferred).
• FDA & OSHA trained and familiar with current regulations (preferred).
• Project management and technical software skills (Excel, Access, etc.) required.
• Project management experience (preferred).
• Experience training in safety, quality, and GMPs (preferred).
• Spanish speaking ability is a plus