Quality Assurance Specialist II

CL f25d5e5c a0fc 46af b026 99878ecf4a3b; Phoenix (AZ); On-site; USD 65,000 - 95,000; Full time

Job summary

Cohere Beauty is seeking a Quality Assurance Specialist to build, uphold, and improve our Quality Systems. The role includes QA tasks, GMP compliance, audits, training, and documentation management onsite.

This role covers entry to senior levels and involves collaborating with manufacturing and regulatory teams to ensure product quality and regulatory compliance while advancing quality initiatives.

Qualifications

• Bachelor’s degree in chemistry or a related science.

Responsibilities

• Support QA tasks and document processes.

Skills

QA documentation

GMP compliance

FDA regulations

Quality systems

Training

Written communication

Organizational skills

Problem solving

Time management

Independent work

Education

Bachelor’s degree in Chemistry or related science

ASQ certifications preferred

Tools

Excel

Access

Project management software

Job description

Cohere Beauty is a diverse team of strategic collaborators, product innovators, R and D formulators, and manufacturing professionals. Built on beauty and rooted in quality, our promise is to collaborate, co-innovate, co-develop, and co-manufacture. Promoting diversity and sustainability through our facilities and supply chains, Cohere Beauty’s approach to social, safety, and environmental responsibility is grounded in a commitment to our employees, customers, and the communities where we live and work. At Cohere Beauty, we’re here for what’s next.

Job Summary

The Quality Assurance Specialist is responsible for performing Quality Assurance (QA) functions to build, uphold, and improve the Company’s Quality Systems.

This is what you will do:

• Applicable to all levels of position
• 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.

Quality Specialist 1 (Considered Entry Level Position therefore requiring most supervision/mentoring)

Quality Specialist II

• Perform at an experienced and functional level therefore requiring limited supervision.
• Engage in Professional Development Activities.

Quality Specialist III (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 IV (All Quality Specialist 1, 2, and 3 skills as well)

• Act as an alternate supervisor in the 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.

This is what you will need:

• Bachelor’s degree, preferably in Chemistry or in physical or biological science.
• 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 or cosmetic 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 safety, quality, and GMPs (preferred).