Job Description
Job Description
Description : POSITION SUMMARY
POSITION SUMMARY
Provide a general overview of why the job exists; and what the job is to accomplish.
Support in the manufacture of Bayer’s rFactor VIII products by performing facility cleaning in accordance to cGMP and safety regulations to minimize any loss of sales.
POSITION DUTIES & RESPONSIBILITIES
List the primary job duties and responsibilities using headings and then give examples of the types of activities under each heading.
- Clean and sanitize equipment and facilities including but not limited to : windows, doors, vents, walls, ceiling, lockers, stairwells, floors, cabinets, sinks, curtains, mirrors, counter tops, bio-safety hoods, handrails, drains, cleaning equipment, and stainless-steel production tanks.
- Maintain housekeeping and ensure that all classified and controlled areas are in clean and sanitize condition; document tasks performed on cleaning check sheets according to building specific SOP.
INTERNAL
- Perform all duties related to cleaning and decontamination of floors. including : sweeping, mopping and scrubbing / buffing.
- Prepare decontamination and cleaning solutions following SOP and BPR Instructions.
- Follow Aseptic techniques when preparing cleaning solution and when taking samples for QC testing. Print sample table form from Score and enter all required data on the form.
Take solution samples and submit samples to QC sample office.
- Follow all cGMP and Safety rules.
- Perform rust abatement if needed.
- Perform related other duties as assigned.
REQUIREMENTS / PREFERENCES
Education Requirement(s) :
- High School diploma - some college preferred
- General knowledge of janitorial and sterile techniques.
- General knowledge of cGMPs; understanding and ability to comply with all cGMP and SOP’s Associated with the job.
Skill & Competency Requirements : (list 3 to 5 non-negotiable items such as years of experience, industry of preference, specific knowledge items, professional certifications, skills, abilities, etc.)
Relevant bio-tech industry experience in some or all of the following is preferred, and may be considered in lieu of some or all of the educational requirements above :
Basic knowledge of protein chemistry and purification systems such as anion, cation, and immunoaffinity chromatography.
Familiarity with cGMP’s and applicable agency regulations.
Preferences : (list nice-to-haves such a specific knowledge items, certifications, skills, abilities, etc.)
- Read, write, speak, and comprehend English in order to understand written and verbal instructions, SOP’s, BPR’s, etc.
- Good verbal and written communication skills.
- Work weekends, holidays and overtime as required.
- Acceptable attendance and performance.
- Able to work both independently / self-directed with minimal supervision and in a team environment.
- Detail oriented with the ability to demonstrate good record keeping practices and ability to follow data integrity rules.
- Computer skills required. Including : ability to learn software applications such as the learning management system (LMS), document control, e-mail (Outlook)
- Must be able to cope with fast paced operations and repeatedly perform multi-step simultaneous operations with high degree of accuracy