Posted to MedZilla on 8/20/2017


ProClinical

United States, Supervisor Manufacturing Cleaning Operations US_QA_CF_13057-MZ


 
 

A technology-focused pharmaceutical company that operates in the US, China and Scandinavia is seek a Supervisor of Manufacturing Cleaning Operations to join their team in Philadelphia, USA. 

Job Role:

  • This Manufacturing Support Services Supervisor role provides on-the-floor supervision and oversight to ensure that off-shift operations are performed and managed efficiently.
  • Demonstrates strong supervisory skills and contributes to the achievement of company and departmental goals and objectives. 
  • Has a strong working knowledge of the regulatory compliance requirements, especially Good Documentation Practices. 
  • Remains current regarding current Good Manufacturing Practices (cGMP) guidelines, especially as they apply to facility cleaning practices / sterility assurance. 
  • Develops and/or revises documents and SOPs to address compliance issues. 
  • Possesses technical knowledge and understanding of facilities / maintenance management as it applies to maintaining cleanroom environments and cleaning effectiveness. 
  • Demonstrates strong oral and written communication skills and actively contributes to training, of off-shift Company or facility cleaning staff.

Role Responsibilities:

  • Work closely with cleaner's on-site management to coordinate operations. Supervise off-shift operations for three cGMP manufacturing buildings
  • Provide clear objectives for Company staff and facility cleaners to meet schedule and cGMP requirements
  • Train, direct and supervise personnel in assigned activities. Ensure facility cleaning is performed per applicable SOPs
  • Work closely with support functions (Quality Assurance, Quality Control, Facilities, Logistics, and Supply Chain representatives) to ensure that off-shift operations are properly resourced to perform their assigned duties and tasks
  • Ensure full compliance with cGMP and applicable health and safety regulations (OSHA)
  • Author and revise applicable SOPs
  • Review documentation and logbooks for completeness and accuracy
  • Conduct checks of facility cleaning effectiveness through audits, inspections, spot checks and walkthroughs. Provide timely and professional feedback to facility cleaner's management and Area Management
  • Identify and report major equipment and facility deficiencies
  • Resolve unexpected issues or problems that occur during off-shift operations. Escalate issues to Area Management as necessary.
  • Author and contribute to deviations/investigations, Corrective/Preventative Action initiatives, Change Control procedures, technical protocols and logistical planning
  • Make on-the-spot corrections to address minor equipment and facility deficiencies or alarms
  • Submit work order requests and work with facilities to drive them to completion in a timely manner
  • Assist Area Management with internal pre-audit walkthroughs, cGMP housekeeping, and general organization and upkeep of manufacturing spaces
  • Contribute data to routine metric reports

Role Requirements:

  • High School diploma and at least 6 years of experience working in a cGMP manufacturing facility or Bachelor's degree with major in Biology, Microbiology, Chemistry or related Science major and 4 - 6 years of experience in a cGMP manufacturing facility or equivalent.
  • Meets physical requirements of the job, as follows: must have the ability to lift a minimum of 50 pounds, stand for long periods, bend, reach, stretch, climb ladders and work in tight spaces in order to complete job tasks.
  • Thorough understanding of regulatory requirements for a cGMP manufacturing facility, especially as they apply to cleaning practices / sterility assurance.
  • Experience with facilities / maintenance management, and work order process
  • Possesses a basic mechanical aptitude
  • Ability to work under limited supervision and to handle problems of a more difficult nature.

To Apply:
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Christopher Frank on +1 267 405 6996 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.


Please visit our website at www.proclinical.com

 
 


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  considered, please do so. Applications for all positions are subject to each employer's specific requirements.