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Caribbean Temporary Services, Llc - Aibonito
Publicado 14 days ago
Disponible a supervisar el tercer turno
Paga es 59,075 anuales
Description:
Supervise processes and personnel in commercial production environment while maintaining cGMP, environmental health and safety guidelines and any other related regulations that apply. In addition to being fully accountable and involved in all production processes, he/she may problem solve in other functional areas. The incumbent acts as a delegate to the Manager and may conduct departmental activities in their absence. He/She fully understands the regulations and may make recommendations according to their interpretations. He/She is responsible for the successful transfer of new processes/methodologies into the manufacturing area Essential Duties & Responsibilities ? Supervise the day to day production, scheduling, staffing, material management, compliance, training, and auditing activities for area of responsibility. ? Develop and manage performance of direct reports. ? Support and ensure execution of all manufacturing processes with strict compliance to cGMPs and EHS regulations. ? Perform or support technical reviews, investigation and process improvement projects. ? Provide input into integration and validation of new equipment and process. ? Resolve technical, material, and cGMP issues. ? Review, approve, and manage documentation for batch and system records for production. ? Interface with other departments to help resolve issues related to equipment, process and compliance including facility support departments and external vendors. ? Lead/participate in technical reviews, investigation and process improvement projects in order to meet objectives ? Assess impact of new regulatory guidelines on current practice, initiate document change proposals, prepare/review protocols to justify process changes, assist with training and auditing as appropriate. ? Owner for implementation of new equipment, system and/or procedures. ? Participate in Internal or external audits as SME for department. ? May perform other duties as assigned. Qualifications The individual should be able to identify errors or faults in process and recommend or implement solutions. ? Basic supervisory and leadership skills. ? Able to manage multiple priorities in manufacturing plant setting ? May have knowledge of Cell Culture, Purification, and Buffer/Media manufacturing operations. ? Understands Manufacturing Production Process for all functional areas. Expertise grows in depth and breadth as individual moves up the career ladder. ? Knowledge of Utility Systems and how they impact the Manufacturing Departments. ? Understands the flow and design/interdependency of manufacturing support departments. ? Knowledge of manufacturing equipment operation, including set up and changeover, as well as commissioning, validation, and troubleshooting. ? Basic scientific understanding of biology (cell culture, microbiology) and chemistry/ biochemistry as it applies to the manufacturing process. ? May have more specific skill sets in areas depending on need/ opportunity: Aseptic technique, column packing, inoculum operations, chromatography operations, etc. ? Knowledge of clean room management. ? Strong professional writing skills and ability to prepare and write technical reports ? Strong verbal and written communication skills across multiple functional areas. ? Computer skills, including PowerPoint, Word, Excel, Access. ? Knowledge of basic chemical and biological safety procedures. ? Incumbent must be proficient in a variety of mathematical disciplines and be able to work with both the metric and USA standards of measurement. ? Must be able to read and follow detailed written instructions and have good verbal/written communication skills. ? Must be able to read, write, and converse in English. ? Must be able to navigate, conduct searches, and fill on line forms on Personal Computer for the purposes of training, performance management, and self service applications. ? Must have the ability to navigate electronic mail systems and intranet for communication purposes. ? Advanced word processing skills. ? Advanced spreadsheet skills. ? Advanced typing skills. ? Good interpersonal skills and be able to work effectively and efficiently in a team environment. ? Must have the following personal attributes: integrity and trust, work ethic, sound judgment, intellectual honesty, pragmatism, courage and conviction. ? Must have passion to innovate and drive for solutions. ? Must display personal accountability for results and integrity. ? Must display eagerness to learn and continuously improve. ? Must have uncompromising dedication to quality. ? Must have relentless focus on rapid and disciplined action. ? Must have respect for individuals and the diverse contributions of all. Education and/or Experience Bachelor?s Degree plus 1-3 years of manufacturing experience, or AA Degree with 3-6 years of manufacturing experience, or HS Diploma with 5-8 years of manufacturing experience. Minimum of 0-2 years of leadership experience. Scientific or engineering 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. ? May work in a cold, wet environment. ? May be exposed to dust, gases, and fumes. ? May be around and operating moving equipment and machinery. ? May climb up and into large processing tanks for cleaning or inspection. ? May be working in a loud area that requires hearing protection and other protective equipment to be worn. ? May work around chemicals such as alcohol, acids, and buffers that may require respiratory protection. ? May be required to work in a confined area as defined by the Environmental, Health, & Safety office. ? Possible exposure to cool/hot storage conditions. ? Will have interaction with other people. ? Pace may be fast and job completion demands may be high. ? May be required to travel for business reasons, e.g. training and meetings . ? May be required to work or be assigned to a different shift as needed. ? Must be able to work more than 8 hours a day or 40 hours a workweek as required. ? This position requires shift, weekend and holiday work. ? Maybe required to work 4 days a week 10 hour days. Physical Demand The overall physical exertion of this position is medium work. ? May be required occasionally to lift up to 50 pounds when completing the following job duty: handling production equipment/materials ? May be required to occasionally push up to 100 pounds when completing the following job duty: handling production equipment/materials/supplies with a manual floor jack. ? May be required to occasionally pull up to 50 pounds when completing the following job duty: handling production equipment/materials/supplies ? May be required to balance rarely when completing the following job duty: use of step ladders in production area ? May be required to carry occasionally when completing the following job duty handling production equipment/materials/supplies ? May be required to climb occasionally when completing the following job duty: use of step ladders in production area or stairwells in work campus ? May be required to crawl rarely when completing the following job duty: troubleshooting production equipment ? May be required to use hand / finger feel constantly when completing the following job duty: use of computer applications and occasionally handle production equipment ? May be required movement of head /neck occasionally when completing the following job duty: use of computer applications with business documents and occasionally handle production equipment ? May be required to grip and grasp occasionally when completing the following job duty: handling production equipment, materials, supplies and filing/storage cabinets ? May be required to use hearing occasionally when completing the following job duty: listening for production and equipment alarms ? May be required to kneel rarely when completing the following job duty: troubleshooting production equipment or working in filing/storage cabinets. ? May be required to stand frequently when completing the following job duty: overseeing production activities ? May be required to walk frequently when completing the following job duty: overseeing production activities ? May be required to drive rarely when completing the following job duty: attend offsite meeting/training ? May be required overhead reaching rarely when completing the following job duty: handling production materials/files/supplies ? May be required to visually inspect frequently when completing the following job duty: overseeing production activities, reviewing production equipment/materials
Job Type: Full-time
Pay: $12.85 - $13.72 per hour
Benefits:
Paid time off
Schedule:
8 hour shift
Experience:
Manufacturing Supervisor: 2 years (Preferred)
Shift availability:
Night Shift (Preferred)
Work Location: In person
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