Calibration and Doc Control Analyst at PACA in Chaska, Minnesota

Job Description:

Apex International is a dynamic, high-quality manufacturer of personal and home care products with an extensive range of capabilities in OTC, cosmetic, and natural products. Apex is a leader in contract manufacturing because of its: • Measurable advantage in quality • Commitment to Lean Manufacturing and continuous improvement • Financial Strength as a privately held, single-owner company • Employees that are great at customer focus and problem-solving

Job Responsibilities and Duties: (Percentages = priority and approximate time focus)

1. Coordinates calibration program by ensuring calibration requirements for multiple facilities are identified, implemented, maintained, and documented to ensure conformance to requirements. 55%
• Works cross functionally to ensure equipment requiring calibration is identified and tracked in MP2.
• Assign appropriate calibration frequencies to new equipment based on manufacturer or internal requirements.
• Queries database for reports detailing which equipment needs calibration for the appropriate period.
• Coordinates and schedules internal or external service provider(s).
• Reviews and approves calibration documentation and initiates OOT reports as required.
• Tracks, trends, and reports out metrics related to calibration program and ensures continuous improvement.

2. Ensures clear, concise and timely document control for multiple facilities is maintained and complies with GMP and procedures and systems. 35%
• Provides backup support for Document Control Analyst
• Manages quality system documentation to include but not limited to standard operating procedures (SOP), work instructions and test methods while monitoring revision control and obtaining signatures and documentation issuance.
• Supports routing and publication of quality system documents
• Accurately records all data (cGMP) and pertinent information.
• Maintains record retention system for Apex International and its customers.
• Coordinates document life cycle storage, retention, and destruction.

3. Understand and maintain a culture of “lean action” within the department so that we live lean better than any organization. 5%
• Implement and maintain standards and processes that eliminate waste throughout the department.
• Apply and utilize “lean tools” to permanently implement improvements.
• Institutionalize 5-S in all aspects of the department. (Sort, Straighten, Shine, Standardize, and Sustain)

4. Perform other work as assigned. 5%

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)

See job description