Quality Operations Lead -1st Shift

Apex International; Chaska (MN); On-site; USD 36,000 - 41,000; Full time

Benefits offered by this job

Medical, Rx, Dental, Vision benefits

Life Insurance & AD&D

401(k) with company match

Disability insurance

Employee Assistance Program

Job summary

Apex International is seeking a Quality Operations Lead for the 1st shift at our Chaska, MN production facility. You will oversee quality in filling and cartoning, ensuring products meet Apex and customer standards.

Work closely with manufacturing to maintain quality systems, follow SOPs, and address quality issues to promote a culture of quality. Requirements include 2+ years in a GMP manufacturing environment and a Bachelor's degree or equivalent.

Qualifications

• 2+ years in a GMP manufacturing environment preferred.
• Bachelor's degree or equivalent experience required.
• Strong attention to detail and ability to follow instructions precisely.
• Proficient in Microsoft Office; able to work with quality documentation.

Responsibilities

• Perform in-process audits of filling lines to ensure quality.
• Complete line paperwork in compliance with SOPs and standards.
• Ensure adherence to SOPs, work instructions, and test procedures.
• Maintain and improve the quality systems within manufacturing.
• Document deviations and OOS events; escalate as needed for decisions.
• Coach manufacturing personnel to improve quality compliance and awareness.
• Apply Lean tools and 5S standards to reduce waste and sustain improvements.

Skills

GMP experience

multitask

attention to detail

MS Office

coaching & communication

Education

Bachelor's degree or equivalent experience

Job description

At Apex International, we pride ourselves on being a high-quality manufacturer of over-the-counter personal care and household products. We create collaborative partnerships with customers ranging from global Fortune 100 companies to entrepreneurial start-ups.

We are currently seeking a Quality Operations Lead, 1st Shift to join our Quality team in Chaska, MN. This role works onsite at our production facility and is responsible for overseeing quality during filling and cartoning operations to ensure products meet Apex and customer quality standards. This position works closely with manufacturing personnel to maintain quality systems, ensure compliance with established procedures, address quality issues, and promote a strong culture of quality and continuous improvement.

Job Duties and Responsibilities

Quality Operations & Compliance

• Perform in-process audits of manufacturing lines to ensure quality throughout the filling process.
• Complete line paperwork accurately and in compliance with company and regulatory standards.
• Ensure compliance with current SOPs, Work Instructions, and test procedures.
• Ensure customer and Apex quality standards are met and maintained.
• Ensure cleaning and sanitization procedures are completed correctly.
• Maintain and improve production's portion of Apex's quality systems to support world-class manufacturing.
• Use established processes and technology to improve the quality and efficiency of production.

Quality Events & Documentation

• Document and investigate deviations and out-of-specification (OOS) situations.
• Ensure quality events, including deviations, non-conformances, and potential issues, are properly documented and escalated to support efficient and effective decision-making.
• Maintain accurate documentation and follow established quality processes, work instructions, and specifications.

Coaching & Quality Awareness

• Coach manufacturing personnel to improve compliance with regulatory and quality requirements.
• Use strong interpersonal and coaching skills to promote quality awareness and help create a culture of quality.
• Work closely with manufacturing personnel to reinforce quality expectations and established procedures.

Lean & Continuous Improvement

• Support and maintain a culture of Lean action within the department.
• Implement and maintain standards and processes that eliminate waste.
• Apply Lean tools to implement and sustain improvements.
• Promote and maintain 5S standards: Sort, Straighten, Shine, Standardize, and Sustain.
• Perform other work as assigned.

Qualifications

• Minimum of 2 years of experience in a GMP manufacturing environment such as pharmaceutical, cosmetics, personal care, food processing, or medical device manufacturing preferred.
• Bachelor's degree or equivalent experience.
• Knowledge of a manufacturing or technical field, ideally within the personal care, cosmetics, or pharmaceutical products industry.
• Ability to understand and follow quality work instructions, SOPs, and specifications.
• Ability to multitask, demonstrate a sense of urgency, and stay organized.
• Strong interpersonal and coaching skills.
• Strong attention to detail with the ability to work accurately and precisely.
• Working knowledge of computer operations and proficiency with Microsoft Office.
• Ability to perform basic math and algebra.

Work Environment & Schedule

• On-site manufacturing environment in Eden Prairie, MN.
• Moderate to high level of physical activity, including extended periods of standing and walking.
• Regular talking, teaching, and repetitive hand and wrist movement.
• Indoor work environment with exposure to various fragrances that may occasionally be at elevated levels.
• Ability to utilize stairways, adapt to changes in the work environment, and work effectively in a fast-paced manufacturing setting.
• Schedule will be based on the assigned shift.
• Flexibility with work hours is required based on business and customer needs.
• Weekend overtime and additional hours beyond the regular work schedule may be required depending on work demands and customer requirements.

Benefits

• Medical, Rx, Dental, and Vision benefits
• Short-Term and Long-Term Disability
• Life Insurance and AD&D
• 401(k) Retirement Plan with company match
• Employee Assistance Program
• $26 - $30 per hour base pay depending on experience