The posting
ROLE SUMMARY Summarize the primary purpose and key responsibilities of the role. It may be helpful to complete this section after you have finished the other sections of the document.
ROLE SUMMARY Supervision of aseptic filling and sterile subassembly operations and (union) operators. Responsible for the aseptic filling of all products assuring processes are performed in compliance with cGMP’s and following Standard Operating Procedures (SOPs).
ROLE RESPONSIBILITIES In order of importance, indicate the primary responsibilities critical to the performance of the role. Identify 5-8 key areas that highlight accountability and level of judgment required. Ensure GMP tasks and those required by regulation are clearly documented.
ROLE RESPONSIBILITIES
Instructs the filling and subassembly operations of (union) operators in the daily duties and assures they are performed in a timely manner and in conformance with cGMP. Supervises operations to ensure adherence with all Safety requirements. Immediately addresses all safety events or concerns with Environmental, Health and Safety (EH&S) personnel. Performs GMP audits of the aseptic processing area as required and investigates any process deviations; perform daily reviews of area batch records for accuracy and ensures compliance with Standard Operating Procedures and adherence to aseptic processing requirements. Composites new or revises departmental SOPs as required. Reports any significant shift activities to the Manager/TL; root cause analysis and ability to define effective corrective/preventative action. Coordinates personnel activities – i.e., vacations, sick time, etc. to ensure there is appropriate coverage in the department at all times; addresses personnel issues as they arise; trains new operators; conducts reviews with operators. Maintains inventory on materials and sterile items used in the aseptic processing area. Maintains and improves labor standards. Assist with the development and maintenance of the annual department overhead budget and orders supplies for area. Schedule shift to maintain hands-on support with operators; fill in for other supervisors as needed. Maintain communications with Manufacturing Resource Coordinators for batch records and SOP’s: coordination of equipment maintenance and repairs with the Tech Services group; with QC Lab to coordinate laboratory testing; with Materials and Planning for scheduling of filling operations and ordering of materials; with Manager/TL to report daily activities and receive information on activities for the area; and with MQA for any quality issues/concerns. Assists the Production Manager with special projects and other duties as assigned. Performs other related duties as assigned.
QUALIFICATIONS Qualifications are job related, consistent with business requirements and necessary for the performance of an essential function of this role including: education requirements the role holder must possess, such as a Bachelors, Masters or Doctorate degree, certifications or other post graduate qualifications, the type and length of experience needed to perform effectively in the role, and the skills, knowledge and attributes a candidate must possess in order to be competent in the position.
BASIC QUALIFICATIONS
Education: Bachelor's degree in Biology, Chemistry, Computer Science or other Technology or Life Science field. Experience: Minimum of two years prior work experience; pharmaceutical background helpful. Prior experience in a union shop setting is helpful. Background in manufacturing and supervision is highly desirable. Language Skills: Effective written and oral communication skills required. Excellent written skills in English. Good verbal communication and ability to coach and provide guidance to others. Computer Skills: Computer literate, with skills in managing Microsoft Applications, Trackwise. Reasoning Ability: Demonstrated reading comprehension and writing proficiency at level that meets ‘role’ and/or ‘test’ requirements. Ability to effectively communicate within a diverse group resulting in desired outcomes. Proven record of problem solving, decision making skills and application of process improvement tools. Physical Demands: Ability to stand upright for several consecutive hours absent of any medical restrictions which could restrict completion of required duties. Additional requirements are line and product specific. Work Environment: Use of eye protection, gloves and other PPE is required. Maintaining aseptic area certification may be required. Aseptic gowning procedures will be required. Aseptic gowning requires all body parts to be completely covered (gowned) for substantial periods of time. Practices and promotes safe working environment at all times. Self-starter, team player, with strong interpersonal and coaching skills Aseptic gowning requires all body parts to be completely covered (gowned) for substantial periods of time. Practices and promotes safe working environment at all times. Self-starter, team player, with strong interpersonal and coaching skills. Other duties as assigned.
Language Skills: Effective written and oral communication skills required. Computer Skills: Microsoft Applications, Trackwise. Reasoning Ability: Demonstrated reading comprehension and writing proficiency at level that meets ‘role’ and/or ‘test’ requirements. Ability to effectively communicate within a diverse group resulting in desired outcomes. Physical Demands: Ability to stand upright for several consecutive hours absent of any medical restrictions which could restrict completion of required duties. Additional requirements are line and product specific. Work Environment: Use of eye protection, gloves and other PPE is required. Maintaining aseptic area certification may be required. Aseptic gowning procedures will be required. Aseptic gowning requires all body parts to be completely covered (gowned) for substantial periods of time. Practices and promotes safe working environment at all times. PHYSICAL/MENTAL REQUIREMENTS Job task may include bending, twisting, and lifting items up to 35lbs at a frequency that meets position requirements. This position requires standing and frequent walking between production areas to supervise operations. This position works around moving machines, is exposed to temperature changes and is required to wear personal protective equipment in certain areas and be gown qualified. NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS Position requires regular on-site attendance – this position cannot be performed on a remote or telecommute basis on a temporary, short- or long-term basis. Must have the ability to simultaneously multi-task across multiple capabilities and functions and handle multiple competing priorities and requirements, including performing site and functional responsibilities, responding to email and phone communications and attending meetings. Note these activities may not be time bound to core hours or presence at the site. Must have the ability to effectively manage strict production, time and performance deadlines. Must be willing to work beyond the hours typically defined as a ‘regular’ work day, which may or may not include weekends and holidays. The job is open only to Protected Individuals (as defined by 8 U.S.C. § 1324b(a)(3), namely, Citizens or Nationals of the United States, Lawful Permanent Residents (“green card holders”), Refugees and Asylees.
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