Would you like to contribute to the success of our customers by ensuring quality through the auditing of the facility and production lines, evaluation of raw material, bulk, and finished products, and continuous improvement efforts.
Job Responsibilities and Duties: (Percentages = priority and approximate time focus)
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.
2. Ensures product quality specifications and customer standards are met and maintained to the Customer’s satisfaction.
3. Utilizes data to focus improvement efforts so customer requirements and regulatory requirements are met
4. Understand and maintain a culture of “lean action” within the department so that we live
lean better than any organization.
5. Perform other work as assigned.
Qualification and Skill Requirements:
Prefer a minimum of 2 years experience in a GMP manufacturing environment such as pharmaceutical, cosmetics, personal care, food processing, etc.
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.
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.
· 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.