$1,000 Hiring Bonus
Perform Quality Assurance (QA) functions to build, uphold, and improve the Company’s Quality Systems.
Essential Duties and Responsibilities:
Applicable to all levels of position
- 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.
Quality Specialist 1 (Considered Entry Level Position therefore requiring most supervision/mentoring)
Quality Specialist 2
- Perform at an experienced and functional level therefore requiring limited supervision.
- Engage in Professional Development Activities.
Quality Specialist 3 (All Quality Specialist 1 and 2 skills as well).
- Subject Matter Expert in Quality Assurance functions and GMP functions.
- Function with little supervision.
- Keep current on industry regulations.
- Perform gap analysis of quality and analyze monthly trending reports of key quality indicators for manufacturing to ensure continuous quality improvement.
- Recommend and implement modifications of existing quality or production standards to achieve optimum quality within limits of equipment capability, i.e. validation support.
- Provide supervisor support on selected, large-scope projects involving data collection and/or research small scope individual topics drafting recommendations to QA management.
- Mentor co-workers and internal customers with interpretation of regulatory requirements (e.g., Good Laboratory Practices (GLPs), SOP requirements, and other guidance documents, as applicable.
- Notify management of quality/compliance trends and service failures.
Quality Specialist 4 (All Quality Specialist 1, 2, and 3 skills as well)
- Act as an alternate supervisor in supervisor’s absence.
- Act as QA subject matter expert.
- Make decisions autonomously.
- Function without minimal supervision.
- Function as a lead with the Supervisor present.
- Develop and implement appropriate programs and systems.
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.
- 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.