GMP Cleaning Associate in King Of Prussia, PA

POSITION TITLE: GMP Cleaning Associate

DURATION: 1 YEAR

100% ON SITE

SHIFT: 12 hour shifts - 3 or 4 days/week including holidays and every other weekend. It's still TBD on the exact hours but it will primarily be geared towards nights (ie. 12pm-12am or 2pm-2am)

JOB PURPOSE:

• To clean the production, lab, and warehouse areas according to site procedures and complying to safety and quality requirements.
• Conduct GMP Cleaning operations in accordance with Biopharm Safety Procedures and cGMPs.
• Off-shift hours (including night work) may be required.

KEY RESPONSIBILITIES:

Safety

• Follow all EHS procedures, standards and PPE requirements
• Notify appropriate personnel of any incident and accident in respective area.
• Raise ZAPs for any EHS concerns.
• Attended Stop for Safety Sessions in respective shift / area

Quality

• Follow GMP procedures
• Report any abnormalities /adverse event to FLL (OLN, Rapid Response, deviation) in a timely manner.
• Perform area cleaning and record per procedure.

Performance

• Adhere to site cleaning procedure and schedule
• Ontime attendance
• Maintain 5S, area cleanness and tidiness.
• Interact professionally with other staff

EDUCATION REQUIREMENTS:

Minimum level of education required –

• Intermediate School - Reading and comprehension skills required to execute GMP Cleaning activities and ensure operations occur in safe, compliant and efficient manner.

Preferred level of education –

• High School

JOB-RELATED EXPERIENCE REQUIREMENTS:

• Minimum of 1 year experience in Sterile or GMP Cleaning operations within Pharmaceutical or Biotechnology industry or 5 or more years of equivalent experience
• Prior experience with pharmaceutical manufacturing
• Familiar with cGMP’s, regulatory guidelines, governmental codes, and standard operating procedures.
• Strong communications skills, both verbal and written.
• Basic knowledge and understanding of safety and GMP requirements.

Why is this level of experience required:

• GMP Cleaners are responsible for providing support to the production operations.
• It is essential the individual have a thorough understanding of the tasks required and the repercussions of their actions.

OTHER JOB-RELATED SKILLS/BACKGROUND:

• Demonstrates proficiency on the following systems: SAP/MERPS, VQD, Syncade, Microsoft software packages.
• Ensure the proper procurement of appropriate materials for tasks.
• Ensure proper documentation is completed appropriately to sufficiently document cleaning tasks.
• Strong quality/compliance orientation and track record.

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