Quality Assurance Specialist II

About the role

The Quality Assurance Specialist II supports the Quality System infrastructure by performing QA tasks, auditing, and maintaining documentation. This role works onsite, Monday through Friday from 6:30 AM to 3:00 PM.

Responsibilities

• 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 facility records files are in conformance to applicable Standard Operating Procedures (SOP) and GMP regulatory requirements.
• Manage the Quality System’s Training Program, ensuring proper documentation systems are maintained.
• 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 as needed.
• Make changes to SOPs, policies, training materials, and other documents in the records management system.
• Absorb and resolve issues during regulatory inspections.
• Interface with various Divisions in problem resolution and continual improvement.
• Support manufacturing failure investigations and define investigational strategy.
• Facilitate meetings and apply discretion in decision-making.
• Communicate effectively with others and perform work onsite.
• Perform other duties as assigned.

Requirements

• 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.
• Prominent 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 manufacturing 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.

Qualifications

• 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.
• Prominent 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 manufacturing 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.

Skills

• Strong written and verbal communication skills.
• Excellent organizational skills.
• Prominent documentation skills.
• Strong problem-solving skills.
• Ability to work independently on multiple projects.
• Ability to read, write, and speak English competently.
• Ability to maintain reliable and predictable attendance.
• Project management and technical software skills (Excel, Access, etc.).
• Project management experience (preferred).
• Experience training in safety, quality, and GMPs (preferred).
• Spanish speaking ability is a plus.

Benefits

Everforth Apex offers a comprehensive benefits package including medical, dental, vision, life, disability, and other insurance plans. Additionally, we provide an ESPP (employee stock purchase program), a 401K program with a company match, and a HSA (Health Savings Account) on the HDHP plan. We also offer a SupportLinc Employee Assistance Program (EAP) with up to 8 free counseling sessions, a corporate discount savings program, and other discounts. Professional development opportunities include an on-demand training program, access to certification prep, a library of technical and leadership courses/books/seminars, and certification discounts and perks for associations like CompTIA and IIBA. Our dedicated customer service team addresses questions about benefits and other resources, and a certified Career Coach is available. For more information, refer to the 'Welcome Packet' provided by an Everforth Apex team member. Everforth Apex is an equal opportunity employer and considers qualified applicants with criminal histories in a manner consistent with applicable law. For ADA accommodations, contact our Benefits Department at [email protected] or 804-523-8228.