Manufacturing Technician - Aseptic

Job Title FLSA Status Non-exempt Starting at $20/hour based on experience plus twice a year bonuses Summary This position requires an individual who can work within a cGMP environment in collaboration with other Manufacturing Technicians and under the direct supervision of the Aseptic Manufacturing Supervisor. The successful candidate must be focused on achieving individual and team productivity goals while maintaining a high level of precision and quality. Essential Duties and Responsibilities Practice current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDocP) at all times Responsible for weighing and mixing products in accordance with cGMP processes, following SOP’s, and providing accurate documentation in production batch records Ensure daily operations run efficiently to maintain anticipated production output and maintain product quality for patient safety Complete batch documentation in accordance with GDocP Participate in equipment preparation for batch manufacturing, when applicable Maintain equipment maintenance logbooks for designated equipment Properly use all equipment (i.e. pH meters, balances, peristaltic pumps, etc.) involved in compounding and aseptic processing operations Assist in the development of Standard Operating Procedures (SOP) and other relevant cGMP documentation related to staging processes Report all unusual, non-routine occurrences when performing tasks (NOE report) Ensure training is up-to-date and assist in training technicians Attend training classes, workshops, meetings, etc., as required to improve job skills and product related procedures Work in collaboration with other members of the manufacturing team and other departments such as quality and facility maintenance to achieve company goals Ability to troubleshoot critical manufacturing processes with appropriate communication and documentation (e.g. batch records, logbooks, and other related documentation) Perform cleaning and maintenance of environmentally controlled areas Abide by all company gowning requirements as well as organizational requirements Coordinate with Supply Chain Technicians to ensure in-stock conditions on all manufacturing materials Demonstrates, at all times, safe work habits and maintains a safe work environment May participate in other Manufacturing Operations as needed Required Education and Experience Minimum high school diploma or general education degree (GED) Experience working in manufacturing is preferred Must develop knowledge of 21 CFR Part 210 and 211 for cGMP operations Must be capable of working with small and large pieces of machinery Must be capable of wearing all protective gear (gown, hair bonnet, mask, beard cover, gloves, goggles) and maintain good personal hygiene (makeup, jewelry, and other cosmetics are prohibited from the production areas) Must be able to perform aseptic gowning and related procedures Must possess strong verbal, written, and oral communication skills Must be able to work independently and with a team Must possess problem-solving skills Ability to recognize priorities and actively make productive use of time to build operational efficiencies Must exhibit punctuality and low absenteeism Able to sit and/or stand 8-10 hours or more per day as needed May need to lift up to twenty-five (25) pounds on occasion Communication Organizational Skills Problem Solving/Analysis Results Driven Technical Capacity Detail Oriented Supervisory Responsibility This position has no supervisory responsibilities. Physical Demands Able to sit and/or stand 8-10 hours or more per day as needed May need to lift up to 25 pounds on occasion Position Type and Expected Hours of Work This is a full-time day shift position. Because of the nature of the business, work schedules may vary at times. Travel No travel is expected for this position. Disclaimer The above job description is intended to describe the general nature and level of work being performed by employees assigned to this job. It is not designed to capture or illustrate a comprehensive list of all responsibilities, duties, and skills required of employees assigned to this job. AAP/EEO Statement Stokes Healthcare is an Equal Employment Opportunity and Affimative Action Employer. #J-18808-Ljbffr Epicur