Job description

Job Summary:

Perform Quality Assurance (QA) functions to build, uphold, and improve the Company’s Quality Systems.

Essential Duties and Responsibilities:

• Support the Quality System infrastructure by performing QA tasks pertaining to 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, 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.
• Maintain a good attendance record.
• Perform work onsite.
• Perform other duties as assigned.
• Perform at an experienced and functional level therefore requiring limited supervision.
• Engage in Professional Development Activities

Required Education, Knowledge, Skills, Abilities:

• Bachelor’s degree, preferably in Chemistry or in physical or biological science.
• Minimum 3 years experience in an 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.
• FDA & OSHA trained and familiar with current regulations.
• Strong problem solving skills.
• Project management and technical software skills (Excel, Access, etc.) required.
• Work well under pressure and able to prioritize workloads.
• Ability to perform risk assessment.
• Experiece 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.

Preferred Knowledge, Certifications, Skills, Abilities:

• Worked in pharmaceutical or cosmetic mfg environment.
• American Society for Quality certifications.
• Project management experience.
• Experience training safety, quality and GMPs.

Environmental Conditions:

• Primarily office environment – climate controlled.
• Periodic visits to:
• Warehouse environment – some temperature extremes, dust and noise.
• Manufacturing environment - some temperature extremes, dust, noise and wet.
• Potential exposure to hazardous chemicals.
• Requires use of PPE such as safety glasses, hairnets, or gloves.