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Über
Location : Eden Praire, MN
Type :Full-Time
Job Responsibilities and Duties:
1.Performs reviews of Production Batch Records to ensure a world class manufacturing control program is maintained with training and first time right as a focus.Ensures documentation records are accurate and in compliance with GDP requirements.
Ensures compliance with current SOPs, Work Instructions, and test procedures.
Trains personnel to improve compliance with regulatory and quality requirements.
Provides technical, process direction, and training to manufacturing personnel.
Utilizes interpersonal skills to help create a culture of quality and increase quality awareness.
Documents and investigates deviations and out of specification (OOS) situations. Ensures that SOPs, Work Instructions, controlled forms, and test methods are updated proactively to support improvements and compliance.
2.Ensures product quality specifications and customer standards are met and maintained to the Customer's satisfaction. Complete approvals to run as needed Ensures that quality events (deviations, non-conformances, potential issues) are properly documented and escalated for efficient, effective decision making.Ensures that products meet specification prior to release. Ensures current reference and product standards are properly maintained.Ensures specifications are updated as needed.
3.Utilizes data to focus improvement efforts so customer requirements and regulatory requirements are met• Accurately records data (cGMP) and pertinent information.Uses data to ensure ongoing quality issues on the floor are permanently resolved.
Documents OOS situations, determines root cause, and suggests possible solutions in order to prevent recurrence of the issue. Maintains compliance with current regulatory expectations and practices (e.g. USP).
4.Understand and maintain a culture of "lean action" within the department so that we live
lean better than any organization.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).
5.Perform other work as assigned.
Direction and oversight of others:
coordinates staff schedules based on direction from supervisor.
Qualification and Skill Requirements:
Prior Experience:
Prefer a minimum of 2 years experience in a GMP manufacturing environment such as pharmaceutical, cosmetics, personal care, food processing, etc.
Knowledge Requirements:
Knowledge normally acquired through a 4-year college degree in Chemistry, Biology or related science discipline and/or equivalent experience is needed.
Working knowledge of cGMP and 21CFR drug manufacturing regulations is needed.
Detailed understanding of Apex quality work instructions and related SOPs is required.
Skills Requirements:
To be effective, this position requires the ability to multi task, demonstrate a sense of urgency, and the ability to organize.
Strong interpersonal skills and coaching skills are required.
Licenses and Certifications:
None
Certifications or required class attendance:
None
Technical Competencies: 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. Has a "working" knowledge of personal computer operation. Proficient at Microsoft Office. Can read and follow written work instructions and specifications. Work Requirement:
This position may require some work hours beyond the normal workday based on the demands of the business cycle, customer volume of business, and specific sales efforts underway. It has a moderate to high demand for physical activity.
Physical Requirements:
This position requires:
Continuous
(6 or more hours per day) standing and walking. Continuous
(6 or more hours per day) talking, teaching, and repetitive motion, hand/wrist movement. Sensory requirements:
Good eyesight, normal hearing, and fluent in the English language. Working Conditions:
Indoors, generally. Will be exposed to various fragrances which at times may be at elevated levels. Able to utilize stairways. Able to respond and adapt to changes in the work environment. Able to work in a high paced work environment.
Work Schedule:
This position usually works for eight (8) hours during the period of 7:00 am to 7:00 pm. However, hours of work are flexible and will fluctuate based on the needs of the business and the customers. The job may require a maximum of 5-15 hours of work beyond the normal weekly work schedule depending on work demands. The work hours can vary depending on customer requirements. This position will require occasional day time or overnight travel.
Sprachkenntnisse
- English
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