Job Description
Job Summary:
- The Serologist I will be responsible for performing quality control testing according to established procedures and timelines.
Duties and Responsibilities:
- Performs in-process, final product, stability and raw material testing using both automated and manual testing methods with a quality mindset.
- Understands how this testing directly impact our customers and the patients they serve
- Conducts Failure investigations to determine rrot cause of out of specification results
- Perform routine maintenance
- Maintain site’s retention sample program
- Set up Bioburden Testing for final produc
- Weekends and OT is occasionally required
- Must be able to lift a maximum of 35 pounds
- Documents results clearly and accurately.
- Interprets results by complying with appropriate specification requirements.
- Works with Quality Information Systems (Windchill, OTIS, SAP).
- Due to being a highly regulated manufacturing site, errors must be minimal.
- Performs all duties with attention to detail and a conscientious approach to documentation
Education and Experience:
- A.S. Degree in Chemistry, Biochemistry, Biology, Microbiology, or a related discipline or an equivalent combination of education and experience.
- Medical Technology/Medical Laboratory Sciences background preferred.
- 0-2 years of experience at a medical or manufacturing facility or equivalent combination of education and experience.
Knowledge, Skills and Abilities:
- Knowledge of Immunohematology and blood banking is preferred.
- Familiarity with the guidelines and regulations of FDA, OSHA, ISO, and cGMP is preferred.
Manual dexterity to handle instruments, complete repetitive motions, and stand for long periods of time is required. - Excellent oral and written communication skills are required.
- Basic knowledge of the Microsoft Office suite of products (Excel, Word, PowerPoint, Outlook) is required.
- The ability to prioritize and handle multiple tasks and challenges at one time is required.
- Ability to work both independently and within a team environment required.
- Strong preference for candidates demonstrating flexibility in working any shift (day and night shifts plus weekends).