Job Details
Qualifications
- Analysis skills
- Bachelor's degree
- Communication skills
- Computer skills
- Databases
- Quality assurance
Benefits
- 401(k) matching
- Dental insurance
- Health insurance
- Paid time off
- Tuition reimbursement
Job Description
Job Title: Senior Quality Assurance Manager
Reports to: Quality Assurance Director
Company: Kobayashi Healthcare, Inc.
Department: Quality Assurance
Job Purpose
Responsible for ensuring Kobayashi products and supplier materials meet the established standards of quality including reliability, usability, and performance both internally and for suppliers, and customers, while meeting all governmental regulatory requirements including FDA when applicable.
Duties and Responsibilities
1. Utilize the Kobayashi Quality Management System and Good Manufacturing practices to ensure compliance to all requirements by developing, conducting, and documenting independent audits.
2. Review and approve batch records for CMO and KAM.
3. Assist with investigations and other actions in support of issuing and closing out quality events (CAPA, NCRs, deviations, change controls, etc.)
4. Oversight, management, and auditing of existing and potential manufacturers or suppliers of chemical, drug and other products used in the manufacture of Kobayashi products.
5. Monitor risk management activities and initiate correction actions when necessary.
6. Assist the Quality Control Department with on-site audits conducted by external providers and develop corrective actions.
7. May perform a wide array of duties in conjunction as directed by the Quality Assurance and Regulatory Affairs Director.
Qualifications
1. Bachelor’s Degree preferred
2. Certifications as Quality Auditor, Quality Engineer, Quality Improvement Specialist, Six Sigma very desirable.
3. Strong computer skills including Microsoft Office and Databases.
4. In depth knowledge of tools, concepts, and methodologies of QA
5. In depth knowledge of relevant regulatory requirements
6. Demonstrated experience in establishing Quality Assurance with minimal support staff.
7. Over the counter pharmaceutical experience highly desirable.
8. Excellent Communication skills-verbal and written
9. Must be able to work with minimal supervision or direction
10. Excellent problem analysis and problem-solving skills
11. Must be able to travel
Working Conditions/Physical Demands
1. Employee will typically work in an office environment but may occasionally work in manufacturing plant, or
2. warehouse, but not substantially exposed to adverse environmental conditions.
3. Physical demands of the job are considered sedentary with minimal lifting, bending, stooping, etc.
4. Worker is required to have close visual acuity to perform administrative duties, view a computer terminal, etc.
Direct Reports
1. None
Job Type: Full-time
Pay: From $1.00 per day
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Health insurance
- Life insurance
- Paid time off
- Tuition reimbursement
Schedule:
- Monday to Friday
Supplemental pay types:
- Bonus pay
Ability to commute/relocate:
- Dalton, GA 30721: Reliably commute or willing to relocate with an employer-provided relocation package (Required)
Application Question(s):
- What are your salary expectations?
Education:
- Bachelor's (Preferred)
Experience:
- Quality assurance: 3 years (Preferred)
Work Location: In person