Senior Quality Assurance Manager

Trustapexinternational; Eden Prairie (MN); On-site; USD 106,000 - 120,000; Full time

Job summary

An established industry player is seeking a Quality Assurance Manager to ensure compliance with regulatory standards in manufacturing. This role involves overseeing product release processes, managing a team of quality analysts, and implementing lean methodologies to enhance operational efficiency. The ideal candidate will bring extensive experience in quality assurance within a manufacturing environment, demonstrating strong leadership and communication skills. Join a dynamic team dedicated to excellence in quality assurance and contribute to the success of our customers through continuous improvement and adherence to best practices.

Benefits

Medical, Rx, Dental and vision benefits

Company paid Short term & Long-term Disability

Company paid Life Insurance

401(k) Retirement Plan with company match

Employee Assistance Program

Cell Phone Data Stipend

10% bonus tied to company performance

Qualifications

• 7+ years of Quality experience, with 5+ in Manufacturing Quality Assurance.
• Bachelor's in Chemistry, Biology, Microbiology or equivalent experience required.

Responsibilities

• Manage product release processes to ensure compliance with regulatory standards.
• Supervise Quality Unit personnel and ensure cGMP compliance in operations.

Skills

Quality Assurance

Lean Methodology

Six Sigma

Verbal Communication

Written Communication

Attention to Detail

Problem Solving

Organizational Skills

Education

Bachelor's Degree in Chemistry

Bachelor's Degree in Biology

Bachelor's Degree in Microbiology

Tools

Microsoft Office

Statistical Analysis Tools

Job description

Job Purpose: To contribute to the success of our customers by ensuring that the Product Release Value Stream operations and processes are cGMP compliant, repeatable and continually meet and exceed our customer's expectations for per specification, on-time delivery, and cost improvement.

Job Responsibilities and Duties:

1. Effectively manage product and packaging material release (disposition) processes to ensure compliance with regulatory and customer requirements.
2. Review and approve quality investigations and deviations to ensure compliance to cGMP.
3. Review and approve Certificate of Analysis, Certificate of Compliance, and other similar cGMP records.
4. Approve review final of Batch Records before release for shipment.
5. Directly supervise Quality Unit personnel involved in quality assurance activities supporting product approval or rejection.
6. Help ensure cGMP compliance by providing indirect supervision of non-Quality Unit personnel who inspect or test product.
7. Ensure that packaging materials and manufactured products are approved or rejected in compliance with cGMP and written procedures.
8. Support the development of a World Class Quality Assurance system.
9. Uses data to ensure that ongoing quality issues on the floor are resolved permanently.
10. Develop processes to ensure that finished goods meet product specifications every time.
11. Uses data and Lean problem-solving tools to drive permanent corrections to reduce deviations and improve quality.
12. Ensures that the Apex Manufacturing Control Program (MCP) is robust and utilizes best practices.
13. Ensures that all sanitation practices are being followed.
14. Management Competencies-Develop and maintain an organization of high performing people who are aligned with our Vision, Purpose and Values.
15. Selection-finds and retains the right people in each position and selects the right candidate.
16. Training-provides employees the skill and information they need to perform their jobs successfully and follows through to ensure learning.
17. Management/Leadership-coaches employees to succeed and develops them for the future.
18. Correction/Redirection-addresses chronic unacceptable performance in a way that causes improvement.
19. Performance Evaluation-objectively values and defines performance against outcomes and standards.
20. Employee development-follows a plan to develop performance and prepare people in their career development.
21. Termination-knows how to document performance and construct a case leading to correct termination decisions.
22. Ensures that customer standards are being met.
23. Proactively communicate project work status based on project requirements.
24. Ensure written documents are clear and timely.
25. Communicate directly with customers as needed or directed.
26. Follow-through to ensure written documents are understood and utilized.
27. Understand and maintain a culture of 'lean action' to influence business processes and drive change within Operations and the Quality Unit.
28. Implement and maintain standards and processes that eliminate waste throughout the department.
29. Apply and utilize 'lean tools' to permanently implement improvements.
30. Institutionalize 5-S in all aspects of the department. (Sort, Straighten, Shine, Standardize, and Sustain)
31. Perform other work as assigned.

Direction and oversight: Directly supervises Quality Assurance Analysts, Quality Specialists. Indirectly supervises personnel outside the Quality Unit who test and inspect manufactured products and packaging materials.

Qualification and Skill Requirements:

Prior Experience: Minimum 7 years of progressive Quality experience with at least 5 years in a Manufacturing Quality Assurance environment such as pharmaceutical, cosmetics, personal care, or food processing. Prior production experience a plus.

Knowledge Requirements: An understanding and familiarity with the principles and their application in a manufacturing setting of 21CFR Part 210 or 211 is desired. To be effective, this position requires the ability to multi-task, demonstrate a sense of urgency and the ability to organize. Experience with lean methodology or Six Sigma a plus. To be effective, this position requires Customer Focus, Constant Improvement and Results Orientation as core character traits. Four years of college resulting in a Bachelor's Degree (in Chemistry, Biology, Microbiology or related technical science) or equivalent experience is required.

Licenses and Certifications: Quality certification is a plus (ASC/CQM, CQA) and Lean/6 Sigma certification preferred.

Certifications or required class attendance: None

Technical Competencies:

• Must demonstrate excellent verbal and written communication skills.
• Ability to respond and adapt to changes in the work environment.
• Must demonstrate proactive work habits and assertiveness in creating and owning quality systems and work processes.
• Is accurate, precise and pays attention to detail.
• Is well organized and thorough in work habits.
• Uses processes and technology to improve the quality and efficiency of service or production; follows processes well.
• Can maintain and grow technical knowledge and expertise. Can be accurate, precise and pay attention to detail.
• Proficient at Microsoft Windows XP and Vista as well as Microsoft Office 2003 or higher.
• Can create, read and follow written work instructions and specifications.
• Can read and write at a college level.
• Can perform advanced mathematics and statistical analysis.
• Understands the relationship between Operations and Quality.

Benefits:

• Annual starting salary range of $$106,000 - $120,000
• Medical, Rx, Dental and vision benefits
• Company paid Short term & Long-term Disability
• Company paid Life Insurance
• Optional Life Insurance for employee, spouse and children
• Flexible Spending Account options for child and health care
• 401(k) Retirement Plan with company match
• Employee Assistance Program
• Cell Phone Data Stipend
• 10% bonus tied to the company's overall performance