What are the responsibilities and job description for the QA Specialist II position at KYYBA, Inc?
Job Description
The Specialist Quality Systems is responsible for providing quality assurance support for some or all of the following manufacturing processes: pharmaceutical products, medical devices, combination products and biologics. Specific areas of support may include the Document Center, Device QA, Labeling, Validation, Training and CAPA. This position will ensure that all product, process or system related quality activities from raw material inspection through shipment of final product are in compliance with Corporate and governmental regulations.
Responsibilities:
• Assist with proper integration and support of quality regulations: drug, biologics, device and/or combination products.
• Assist project teams in planning, preparation, review and approval of quality documentation.
• Complete and route change requests for process document creation, maintenance, and implementation.
• Create quality system documentation and specifications with guidance from technical teams following approved templates and guidelines.
• Assist with or co-lead audits of documentation, facilities and equipment.
• Assist in the design of effective quality systems, procedures and/or processes within cross functional teams to ensure compliance as well as efficiency throughout our quality system.
• Perform assessments to determine compliance to processes and regulations to identify potential gaps and mitigate and implement improvements within our quality system.
• Participate in training and education programs for various aspects of quality assurance.
Qualifications:
• Bachelor’s Degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering or other technical/ scientific area preferred.
• 3 years’ experience in quality assurance, quality oversight or relevant experience.
• Technical knowledge in as many of the following areas as possible: Quality, Regulatory, Process Sciences, Manufacturing Operations.
• Knowledge and familiarity with product, process, equipment, and facilities of pharmaceutical, biological or device related products preferred.
• Knowledge of QA systems and GMP compliance requirements including regulations and standards affecting device, biologics, and pharmaceutical products preferred.
• Experience working in both team setting and independently. Works well with manager guidance to complete tactical objectives while able to manage own time effectively.
• Strong oral and written communication skills needed.
• Excellent interpersonal skills a plus.
• Runs small projects to deliver tactical results.
Years of experience/education and/or certifications required:
• Bachelor’s Degree
• 3 years’ experience in quality assurance, quality oversight or relevant experience.
What are the top 3-5 skills requirements should this person have?
• Quality mindset
• MS Office (Excel-average experience)
• Knowledge of QA systems and GMP compliance requirements including regulations and standards affecting device, biologics, and pharmaceutical products preferred.
• Strong oral and written communication skills needed
• Experience working in both team setting and independently. Works well with manager guidance to complete tactical objectives while able to manage own time effectively.
What is a nice to have (but not required) regarding skills, requirements, experience, education, or certification?
• Bachelor’s Degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering or other technical/ scientific area preferred.
• Knowledge and familiarity with product, process, equipment, and facilities of pharmaceutical, biological or device related products preferred
Work Schedule (Define days,# of hours)/ Is Overtime offered or required?
• Standard 40-hour workweek (start time 7, 8 or 9am)
Does this position offer the ability to work remotely on a regular basis or is it an on-site role?
• (Hybrid- 3 days onsite; 2 days remote) have to be local- training is onsite)
About Kyyba:
Founded in 1998 and headquartered in Farmington Hills, MI, Kyyba has a global presence delivering high-quality resources and top-notch recruiting services, enabling businesses to effectively respond to organizational changes and technological advances.
At Kyyba, the overall well-being of our employees and their families is important to us. We are proud of our work culture which embodies our core values; incorporating value, passion, excellence, empowerment, and happiness, creates a vibrant and productive atmosphere. We empower our employees with the resources, incentives, and flexibility that they need to support a healthy, balanced, and fulfilling career by providing many valuable benefits and a balanced compensation structure combined with career development.
Disclaimer:
Kyyba is an Equal Opportunity Employer.
Kyyba does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other basis covered by appropriate law. Minorities / Females / Protected Veterans / Individuals with Disabilities are encouraged to apply. All employment is decided on the basis of qualifications, merit, and business need.
Rewards:
Medical, dental, vision
401k
Term life
Voluntary life and disability insurance
Optional Pre-paid legal plan
Optional Identity theft plan
Optional Medical and dependent FSA
Work-visa sponsorship
Opportunity for advancement
Long-term assignment with opportunity for hire by client
SELECT AWARDS
The Specialist Quality Systems is responsible for providing quality assurance support for some or all of the following manufacturing processes: pharmaceutical products, medical devices, combination products and biologics. Specific areas of support may include the Document Center, Device QA, Labeling, Validation, Training and CAPA. This position will ensure that all product, process or system related quality activities from raw material inspection through shipment of final product are in compliance with Corporate and governmental regulations.
Responsibilities:
• Assist with proper integration and support of quality regulations: drug, biologics, device and/or combination products.
• Assist project teams in planning, preparation, review and approval of quality documentation.
• Complete and route change requests for process document creation, maintenance, and implementation.
• Create quality system documentation and specifications with guidance from technical teams following approved templates and guidelines.
• Assist with or co-lead audits of documentation, facilities and equipment.
• Assist in the design of effective quality systems, procedures and/or processes within cross functional teams to ensure compliance as well as efficiency throughout our quality system.
• Perform assessments to determine compliance to processes and regulations to identify potential gaps and mitigate and implement improvements within our quality system.
• Participate in training and education programs for various aspects of quality assurance.
Qualifications:
• Bachelor’s Degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering or other technical/ scientific area preferred.
• 3 years’ experience in quality assurance, quality oversight or relevant experience.
• Technical knowledge in as many of the following areas as possible: Quality, Regulatory, Process Sciences, Manufacturing Operations.
• Knowledge and familiarity with product, process, equipment, and facilities of pharmaceutical, biological or device related products preferred.
• Knowledge of QA systems and GMP compliance requirements including regulations and standards affecting device, biologics, and pharmaceutical products preferred.
• Experience working in both team setting and independently. Works well with manager guidance to complete tactical objectives while able to manage own time effectively.
• Strong oral and written communication skills needed.
• Excellent interpersonal skills a plus.
• Runs small projects to deliver tactical results.
Years of experience/education and/or certifications required:
• Bachelor’s Degree
• 3 years’ experience in quality assurance, quality oversight or relevant experience.
What are the top 3-5 skills requirements should this person have?
• Quality mindset
• MS Office (Excel-average experience)
• Knowledge of QA systems and GMP compliance requirements including regulations and standards affecting device, biologics, and pharmaceutical products preferred.
• Strong oral and written communication skills needed
• Experience working in both team setting and independently. Works well with manager guidance to complete tactical objectives while able to manage own time effectively.
What is a nice to have (but not required) regarding skills, requirements, experience, education, or certification?
• Bachelor’s Degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering or other technical/ scientific area preferred.
• Knowledge and familiarity with product, process, equipment, and facilities of pharmaceutical, biological or device related products preferred
Work Schedule (Define days,# of hours)/ Is Overtime offered or required?
• Standard 40-hour workweek (start time 7, 8 or 9am)
Does this position offer the ability to work remotely on a regular basis or is it an on-site role?
• (Hybrid- 3 days onsite; 2 days remote) have to be local- training is onsite)
About Kyyba:
Founded in 1998 and headquartered in Farmington Hills, MI, Kyyba has a global presence delivering high-quality resources and top-notch recruiting services, enabling businesses to effectively respond to organizational changes and technological advances.
At Kyyba, the overall well-being of our employees and their families is important to us. We are proud of our work culture which embodies our core values; incorporating value, passion, excellence, empowerment, and happiness, creates a vibrant and productive atmosphere. We empower our employees with the resources, incentives, and flexibility that they need to support a healthy, balanced, and fulfilling career by providing many valuable benefits and a balanced compensation structure combined with career development.
Disclaimer:
Kyyba is an Equal Opportunity Employer.
Kyyba does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other basis covered by appropriate law. Minorities / Females / Protected Veterans / Individuals with Disabilities are encouraged to apply. All employment is decided on the basis of qualifications, merit, and business need.
Rewards:
Medical, dental, vision
401k
Term life
Voluntary life and disability insurance
Optional Pre-paid legal plan
Optional Identity theft plan
Optional Medical and dependent FSA
Work-visa sponsorship
Opportunity for advancement
Long-term assignment with opportunity for hire by client
SELECT AWARDS
- An INC 5000 company for 10 years
- Corp! Michigan Economic Bright Spots
- Crain’s Detroit Business Top Staffing Service Companies in Detroit
- TechServe Alliance Excellence Award- IT and Engineering Staffing & Solutions
- Best of MichBusiness winner in HR Wizards & Partnerships
- Metro Detroit Elite Category: Recruitment, Selection & Orientation for 101 Best & Brightest
- 101 Best & Brightest Companies to Work for in Michigan
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