Schedule: Wed - Sat, 12pm - 10:30pm
Summary The Manufacturing Associate I is responsible for executing all manufacturing department processes while strictly adhering to cGMP, environmental health and safety guidelines and any other related regulations that could apply. The Manufacturing Associate I is expected to fully participate in both departmental projects and any quality working teams that may be applicable. This position shall be responsible for the hands on execution of activities as they relate to the manufacturing of products. All of the specific requirements presented in this job description are applicable to the functional area in which it resides. Essential Duties & Responsibilities Clean, Set up, operate, and teardown of equipment in the department such as tanks, filtration systems, room sanitization, etc. Complete relevant paperwork following GDP/GMP guidelines. Will be responsible for training on the manufacturing process. Manually clean portable equipment and small parts. Work with other departments to ensure adherance to production schedule. Operate general production equipment (such as pH and conductivity meters, autoclave, portable mixers, etc.). Monitor and record critical process parameters. Write, revise and review pertinent documentation as appropriate. Perform routine maintenance and cleaning of production equipment to maintain equipment in GMP fashion. Prepare media and buffers solutions. Perform sampling using aseptic techniques. Receive and distribute supplies into production area as necessary. Execute Minor Document Change Control. Issue Documents. Generate Work Orders. Assist with process/equipment validation and data analysis. Understanding of supplier/customer procss streams and interdependencies. Troubleshoot and identify atypical conditions and how to respond to them. May train others on complex processes and explain process to others. Participate on Continuous Improvement Teams. May perform other duties as assigned. Qualifications Understanding and compliance in Standard Operating Systems, Current Good Manufacturing Processes (cGMP) & Good Documentation (GDP). Knowledge of basic laboratory and pharmaceutical production equipment including but not limited to: autoclaves, process tanks, incubators, analytical equipment and CIP/SIP systems Must be able to read, write and converse in English. Must be able to read and follow detailed written instructions and have good verbal/written communication skills. Must be proficient in a variety of mathematical disciplines and be able to work with both the metric and US standards of measurement. Must have good interpersonal skills and be able to work effectively and efficiently in a team environment. Must be able to work in a clean room environment wearing special garments. Additionally, personal protective equipment must be worn due to safety requirements. May require immunization before performing work within the manufacturing area. Must have a basic scientific understanding of microbiology, chemistry, sterility, and lyophilization as it applies to the manufacturing process. Must have working knowledge of basic aseptic practices. Must have the knowledge and ability to use a personal computer, electronic mail systems and navigate and conduct searches on the intranet. Must have knowledge of basic laboratory and pharmaceutical production equipment and operation. Ensure safety, security, and the environment in all aspect of the daily activities and any potential safety hazardous are addressed and corrected immediately. Must have and display the following personal attributes: Integrity and trust, work ethic, sound judgment, intellectual honesty, pragmatism, courage. Must demonstrate the following shared values: Must have passion to innovate and drive for solutions, must display personal accountability for results and integrity, must have uncompromising dedication to quality, must have relentless focus on rapid and disciplined action, must have personal accountability Must have and display the following Leadership Expectation competencies: Critical Thinking and Problem Solving, Communication, Business Acumen, Collaboration and Teamwork, Motivating and Developing Others, Dealing with Ambiguity and Customer Focus. The position requires shift, weekend, and holiday work. Overtime may be requied at times Education and/or Experience Requires Bachelors degree or AA degree with 2 years of related work experience or a high school diploma with a minimum of 4 years of related work experience. Scientific degree preferred. Working Environment Must be able to work in controlled or clean room environments requiring special gowning. Will be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet and body. No make-up, jewelry, contact lenses, nail polish or artificial fingernails may be worn in these work environments. Will have interaction with other people. Pace may be fast and job completion demands may be high. This position requires shift, weekend and holiday work. Overtime may be required at times. May be required to work or be assigned to a different shift as needed.
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The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.