GMP Cleaner

Houston TX

Description

Date: 3/16/2020 Job Title: Jan-GMP Associate Department: Environment Services Work Location: PL-1 and PL-2 Manufacturing Areas/Suites Travel Requirements: <10% = low Reports To (Position): Contract Account Manager or Supervisor Role Purpose: Perform shift/daily sanitization schedule. Observe expiries for consumables, cleaning solutions in MALs, PALs as well as sanitization activities, ensure it is within acceptable range prior of beginning of tasks. Ensure completion of tasks per assigned SOPs; Associates are responsible for supporting all cGMP manufacturing production suites by performing all tasks as outlined on assigned SOPs, perform daily WFI hose sanitizations, making up solutions as outlined on SOP and log activities in written and electronic documents in accordance with good manufacturing practice (GMPs) and good documentation procedures (GDPs), review documentation as appropriate. They are expected to attain an advanced understanding of cGMP compliance while training associates under close supervision, demonstrating aseptic technique and cross contamination awareness in handling of products and materials. % of Time Minimum 10% List highest % first Primary Accountabilities, Duties and Responsibilities List 4 – 6 primary duties and responsibilities of this position which are accomplished through the physical, environmental and mental demands identified below. Begin with the largest percentage and end with the smallest (to total 100%). Begin each sentence with an action word, e.g., Provides appropriate coaching and performance feedback to all direct reports. 40% Perform shift/daily sanitization schedule. Observe expiries for consumables, cleaning solutions in MALs, PALs as well as sanitization activities are within acceptable range prior of beginning of tasks. Ensure completion of tasks per assigned SOPs; Associates are responsible for supporting all cGMP manufacturing production suites by performing all tasks as outlined on assigned SOPs, perform daily WFI hose sanitizations, making up solutions as outlined on SOP. Ensure organization of equipment/tools at the end of each day. Report all activities in written and electronic documents in accordance with good manufacturing practice (GMPs) and good documentation procedures (GDPs), review documentation as appropriate. 20% Attain qualification for all assigned tasks and maintain individual training plan 20% Prepare materials for transport and delivery to manufacturing suites. Perform material movements into, out of, and across the production areas. 10% Administrative tasks – attending shift exchange, meetings, sending/receiving emails, participating in projects, perform other duties as assigned. 10% Maintain facility and equipment through routine cleaning and sanitization. Ensure organization of equipment used for transportation of materials/supplies. Perform other duties as assigned. Supervision Received Indicate one level of supervision the incumbent is expected to need from the 5 levels below. ☒Close Supervision The incumbent is assigned duties according to specified procedures and receives detailed instructions. Work is checked frequently. ☐Supervision The incumbent performs a variety of routine work within established policies and procedures, and receives detailed instructions on new projects and assignments. ☐General Supervision The incumbent normally receives little instruction on day-to-day work and receives general instructions on new assignments. ☐Direction The incumbent establishes methods and procedures for attaining specific goals and objectives, and receives guidance in terms of broad goals. Only the final results of work are typically reviewed. ☐General Direction The incumbent exercises wide latitude in determining objectives and approaches to critical assignments. Supervision Given Responsible for planning and assigning work, hiring, pay increases, performance management and disciplinary issues. Directly Through Others Number of Employees Supervised 0 0 Essential Job Functions The demands described below are those essential functions that an employee must be able to accomplish in order to perform this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Marginal or non-essential functions should not be listed. Please note that regular and reliable attendance is an essential function of every position and should not be listed separately below. Work Schedule 12 Hours per Day with a 36/48 work rotation weekly Travel <10% = low; Safety Must know and follow job safety procedures, attend required health and safety training, proactively promote safety at work, and promptly report actual and potential accidents and injuries. Must comply with safety policies of the company and site. Employee owns their own safety and the safety of others. Quality Responsibility Adherence to cGMPs is required at all times during the manufacture of APIs. All personnel own the quality of what they deliver and are responsible for notifying responsible management in a timely manner of regulatory inspections, serious GMP deficiencies, process deviations, product defects and related actions. Environmental Demands The normal working environment is: Production Floor setting, requiring PPE, gowning, safety shoes and glasses. Physical Demands JOB REQUIRES Continuous Frequent Occasional Part of day 100%-67% 66%-34% 33%-1% Bending X Kneeling X Squatting X Climbing stairs X Climbing ladders X Walking X Sitting X Reaching X Driving X Fine motor skills X Gowning X Standing X Lifting 25lbs 50lbs Mental Demands Must have the ability to comprehend process flow and identify factors which influence the process. Must be able to read and follow defined SOPs and policies, work independently on basic manufacturing tasks, identify and communicate non-routine events, and review more complex decisions with Supervisors. Must be able to use automated process equipment and tools. Minimum Required Qualifications/Skills Education High School Diploma or Equivalent minimum; AS/BS preferred Preferred area of study: N/A Experience 0-3 years’ experience; some prior experience in a manufacturing setting preferred. Licenses or Certifications None required Knowledge Proven logic and decision making abilities, critical thinking skills Skills Strong written and verbal communication skills are required Qualities & Attitude The employee is living the cultural beliefs with the flexibility to adapt to changing business priorities. Is open to and actively seeks out feedback on their performance and translates that feedback into action. This job description has been developed based upon the expected and current duties, responsibilities and requirements for the position. Because job requirements evolve with the changing needs of Lonza’s business, this description is subject to change and may be modified at any time, whether formally or informally. Manager’s Signature Date Employee’s Signature Date **Required to be completed for job posting purposes** External Job Description/ Overview: Overview/Role Purpose: Determine part/product expiries and replace required for each area/suite. Collect soiled gowns and deliver to appropriate location per procedure. Restock shelves/dispensers with appropriate items. Perform sanitization of locker rooms. Report all activities in written and electronic documents in accordance with good manufacturing practice (GMPs) and good documentation procedures (GDPs), review documentation as appropriate. They are expected to attain a basic understanding of cGMP compliance while training under close supervision, demonstrating aseptic technique and cross contamination awareness in handling of products and materials. Key Accountabilities and Duties: • Perform 6S and stock the determined areas daily. • Rinse/dry all cleaned parts and store them in determined location. • Assemble/Sterilize restocking items and deliver to determined areas. • Report stock levels for reorder as required per procedure. • Report all activities in written and electronic documents in accordance with good manufacturing practice (GMPs) and good documentation procedures (GDPs), review documentation as appropriate. • Attain qualification for all assigned tasks and maintain individual training plan • Prepare materials for transport and delivery to manufacturing suites. Perform material movements into, out of, and across the production areas. • Maintain facility and equipment through routine cleaning and sanitization. • Administrative tasks – attending suite shift exchange, meetings, sending/receiving emails, participating in projects, perform other duties as assigned. • Perform other duties as assigned. Minimum Required Qualifications/Skills: • High School Diploma or Equivalent minimum; AS/BS preferred • 0-3 years’ experience; some prior experience in a manufacturing setting preferred. • Proven logic and decision making abilities, critical thinking skills • Strong written and verbal communication skills are required • The employee is living the cultural beliefs with the flexibility to adapt to changing business priorities. Is open to and actively seeks out feedback on their performance and translates that feedback into action. Hours will be from 4pm – 12:30 am, Monday – Friday. We have a rotating shift, meaning the days of week will change monthly (Monday – Friday or Wednesday – Sunday, same times) If you would like to apply for this position please contact Camila at 832-712-7709`