Document Control Administrator with Apex International - Apex International

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 seek a Document Control Administrator for our Eden Prairie location. This role will report to the Quality Manager and ensure regulatory and customer requirements concerning document control and quality systems are maintained within compliance.

Job Responsibilities and Duties

1. Ensures quality specifications/systems are met and maintained to the internal and external customer's satisfaction.

• Reviews assigned specification sections to ensure completeness and correctness throughout systems.
• Facilitates revisions to new procedures as requested or recommends new revisions to meet quality systems requirements.
• Ensures the training program is monitored, maintained, and regularly compliant.

2. Ensure changes to quality systems are documented and evaluated through the change control process.

• Maintain the change control system in compliance with requirements.
• Ensure documentation for changes is complete and filed appropriately through cross-functional teams.
• Initial review of production batch records for content and formatting.

3. Ensures clear, concise, and timely document control is maintained and complies with GMP and procedures and systems.

• Manages quality system documentation to include but not be limited to standard operating procedures (SOP), work instructions, and test methods while monitoring revision control and obtaining signatures (internal and external) and documentation issuance.
• Oversees routing and effectiveness of quality system documents.
• Record retention system for Apex International and its customers.
• Problem-solving various quality system issues to maintain system functionality and comply with
  regulations

4. Cross-functional task management.

• Coordinating with Supply Chain, R&D, Quality, Project Management, and other departments to ensure tasks and documents are effective and timely.
• Regulatory and Customer Audit support

5. Perform other work as assigned and applicable.

Qualification and Skill Requirements

• Prefer a minimum of 1-2 years experience in a document control role in a regulated industry such as
  pharmaceutical, cosmetics, personal care, food processing, etc.
• Associate's degree or the equivalent work experience.

Knowledge Requirements

• To be effective, this position requires the ability to multitask, demonstrate a sense of urgency, and organize.
• A proficient user of Microsoft Windows and Microsoft Office is a must. Working knowledge of Microsoft Access is desirable.
• A proficient user of various electronic documentation systems (eDMS) or quality systems (eQMS) is preferred.
• Licenses and Certifications: None
• Certifications or required class attendance: None
• Direction and oversight of others: None
• Must demonstrate excellent verbal and written communication skills.
• 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.
• Can read and follow written work instructions and specifications.
• Can perform mathematic addition, subtraction, multiplication, and division using all units of measurement.

Benefits

• Medical, Rx, Dental benefits
• Short term & Long-term Disability
• Life Insurance
• HSA/Flexible Spending Accounts
• 401(k) Retirement Plan with company match
• Employee Assistance Program

Additional Information

Apex International's dynamic nature, unwavering commitment to quality, implementation of Lean Manufacturing practices, financial strength, unwavering focus on customer satisfaction and problem-solving employees have propelled us to become a prominent industry leader in contract manufacturing for the personal and home care sector.

As a leader in contract manufacturing, Apex stands out due to:

1. Unrivaled commitment to quality: Apex sets itself apart with its measurable advantage in delivering products of the highest quality standards.
2. Emphasis on Lean Manufacturing and continuous improvement: Apex is dedicated to implementing Lean Manufacturing practices, constantly seeking ways to optimize processes and enhance efficiency.
3. Financial Strength as a privately held, single-owner company: As a privately held company with strong financial stability, Apex ensures reliability and long-term partnership opportunities.
4. Customer-focused and problem-solving employees: Apex boasts a team of highly skilled and dedicated employees who excel in customer service and possess exceptional problem-solving abilities. Our commitment to meeting customer needs is unparalleled.

Apex International Inc. is an equal-opportunity Employer.