Exact Job Title: GMP Cleaning Associate
KOP, PA
12 months
Max PR: $22.00/hr.
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)
Required:
• high School Diploma **This is also the preference**
• 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.
Job Description:
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.
Job Responsibilities:
• 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 & Qualifications
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.