Share Email Opening Title Supervisor, Manufacturing  Category Manufacturing   Description Primary Objective of Position The Manufacturing Supervisor position is responsible for implementing and supervising daily (shift) activities in a specific production area to ensure manufacturing goals, production schedules, and project deadlines are met while maintaining compliance, environment health and safety guidelines and any other regulations that apply. Major Duties/Responsibilities Demonstrate the ability and knowledge required to effectively operate production equipment used in area supervises. Assist manufacturing management in the daily operation of the department Participate in process investigations, manufacturing equipment qualification, process validation activities, and internal audits of manufacturing area. Inspect the manufacturing rooms for cleanliness, neatness, and safety. Troubleshoot and notify maintenance/facilities to fix any processing and mechanical problems. Order all component inventory supplies (sample bottles, etc.) Work together with Material Services on all warehouse issues relating to in-process, raw materials, and finished manufacturing product. Submit and/or maintain and distribute reports related to attendance, labor, efficiency, safety, scrap and others as needed. Ability to utilize resources and raw materials in the most efficient and productive manner possible. Co-ordinate daily processing schedules against the manufacturing schedule (daily drumming checklist, equipment calibration, daily sample sheet, major/minor cleans). Ensure batch records are accurate prior to QA review. Communicate to and co-ordinate manufacturing activities with the Process Controller, Manufacturing Management, and Manufacturing Planner. Monitor access, entrance, and security of controlled substances in the vault and during processing for manufacturing employees and ensure appropriate documentation is completed. Maintain a safe work area and monitor Manufacturing Associates to ensure adherence to all SOPs, Safety and Company policies. All other duties as assigned by management Lead or Supervisory Responsibilities Directly supervises work of others, including planning, assigning, scheduling and reviewing work, ensuring quality standards. Is responsible for hiring, terminating, training and developing, reviewing performance and administering corrective action for staff (may be subject to final approval by leadership). Plans organizational structure, position content and staffing. Approximate number of people within supervisory scope: 15   Position Requirements Minimum Job Qualifications Education/Experience BS/BA degree in Business, Technical or Science discipline with a minimum of 4 years of manufacturing experience with solid oral dose pharmaceutical manufacturing experience and a minimum of 3 years in a role directly supervising people is highly preferred. As an alternative, we will consider the following: HS Diploma with a minimum of 15 years of manufacturing experience with solid oral dose pharmaceutical manufacturing experience and a minimum of 10 years in a role directly supervising people; or Associates Degree with a minimum of 7 years of manufacturing experience with solid oral dose pharmaceutical manufacturing experience and a minimum of 5 years in a role directly supervising people Knowledge/Skills/Abilities Strong understanding of solid oral dose manufacturing processes and equipment, including granulation, encapsulation, tableting, coating, etc. Ability to understand cGMPs and other regulatory guidelines applicable to medical/pharmaceutical industry. Ability to manage multiple priorities in a manufacturing environment. Strong professional writing skills and ability to prepare technical reports. Demonstrated interpersonal and leadership skills with the ability to interact with other departments and effectively and efficiently lead others in a team environment. Solid working knowledge of MS Office 98/2000 (Word, Excel, PowerPoint, Access, Outlook), Internet. Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, graphs and charts, or governmental regulations. Ability to write reports, business correspondence, and procedures. Ability to effectively present information and respond to questions from groups of managers, clients, customers, the general public and government regulated agencies. Ability to add, subtract, multiply and divide in all units of measure, using whole numbers, common fractions and decimals. Ability to compute rate, ratio, and percent to draw and interpret bar graphs. Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form. Physical and Mental Demands and Work Environment The physical and mental demands and work environment described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. Physical Demands The employee must be able to be fit tested to wear a respirator for occasional use. The employee must occasionally (5% of the time) lift and /or move up to 20 pounds, occasionally (10% of the time) lift and/or move up to 100 pounds (racks and tanks on wheels, pallet jacks). Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and the ability to adjust focus. Must have corrected visual acuity of 20/40 or better bilaterally. Must be able to pass color/contrast testing passing 9 of 12 elements and must be able to pass a peripheral assessment at 80º or better. While performing the duties of this job, the employee is frequently (up to 70% of the time) required to stand. The employee is frequently required to walk; reach with hands and arms; stoop, kneel, crouch, or crawl and talk or hear. The employee is occasionally required to sit; use hands to finger, handle, or feel and climb or balance. Mental Demands While performing the duties of this job, the employee is regularly required to use English written and oral communication skills; interact appropriately with staff, management contractors, vendors and others encountered in the course of work; read and interpret a variety of documents and instructions furnished in written, oral, diagram, or schedule form such as safety rules, operating and maintenance instructions, and procedure manuals; collate and interpret technical and engineering data; generate technical reports of investigations; analyze and solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists; establish priorities and work on multiple assignments and projects concurrently. The employee is regularly required to apply computer skills covering word processing, spreadsheet and presentation software. The employee is regularly required to apply mathematical formulae and engineering rules of thumb to tasks and execute technical and engineering calculations. Work Environment As with all Recro positions, the person in this position is responsible for carrying out all duties in a safe and responsible manner. In certain assignments, the employee will occasionally work around moving mechanical parts, fumes or airborne particles, and toxic or caustic chemicals. The noise level in the work environment is usually moderate to loud.   About the Organization Societal is a bi-coastal contract development and manufacturing organization (CDMO) with expertise to deliver on our client's needs, regardless of complexity level. These projects span pre-Investigational New Drug (IND) development to commercial manufacturing and packaging for a wide range of therapeutic dosage forms. We provide industry leading support for small molecule therapeutic development, end-to-end regulatory support, clinical and commercial manufacturing, aseptic fill/finish, lyophilization, packaging and logistics services to the global pharmaceutical market. We do all of this in our best-in-class facilities in San Diego, California and Gainesville, Georgia. New hires will pass a background check and drug screen as a condition of employment.   EOE Statement We are an EOE dedicated to a diverse workforce and a Drug-Free work environment. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other characteristic protected by law. If you require an accommodation to complete the application or interview process, please contact careers@societalcdmo.com.   EmpID None Specified  This position is currently not accepting applications. To search for an open position, please go to http://Societal.appone.com WE ALSO RECOMMEND Other Jobs Within Same Category -- None found -- Other Jobs Within 60 Miles -- None found --

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