Serologist (ONSITE)

Please note that this is a 3 month contract position. 

Qualifications:
An Associates degree in Medical Technology, Biology, Chemistry or a related field of study. A minimum of 5 years’ experience at a medical or manufacturing facility, Excellent computer skills, including Microsoft Office and a minimum of 1-3 years’ experience with QC, GMP, and analytical procedures is required. Experience with analytical instrumentation such as AutoVue and ProVue is preferred. Familiarity with the guidelines and regulations of FDA, OSHA, ISO and cGMP is preferred. Knowledge of Quality Information Systems (Windchill, OTIS, cGMP’s). Manual dexterity to handle instruments, complete repetitive motions, and stand for long periods of time is required. Diligent use of PPEs (Personal Protective Equipment) to limit exposure to bloodborne pathogens is required. Excellent oral and written communication skills are required. Proficiency with the Microsoft Office suite of products (Excel, Word, PowerPoint, Outlook). 

Responsibilities:
The Serologist will be responsible for performing in-process testing all types of MTS Gel Cards. This person will assure compliance with company standards and applicable regulatory agencies. He/She will participate in failure investigations to help determine root cause, track and trend data, identify and suggest process improvements to improve business measures.
The Serologist will perform testing within established timelines in accordance with current cGMP’s. He/She will participate in equipment maintenance/calibration program. The successful candidate will have the ability to prioritize and handle multiple tasks and challenges at one time and have the ability to work in a team environment and provide customer focused results in an efficient manner.

Position Summary:
This position will be responsible for performing the formulation of solutions, dilutions of Polyclonal and Monoclonal antibodies, testing, inspection, gel treatment and antibody to gel. Serological testing of stages two and three for Monoclonal antibodies, and stage 3 for Polyclonal antibodies. Chemistry testing for stages 2 and 3, instrument calibration, cleaning of equipment used for production and any other related activities required in the preparation of gel card manufacturing to ensures product meets specification.

Major Duties and Responsibilities:
40% Serological testing of stages two and three for Monoclonal antibodies and stages three for Polyclonal antibodies. Chemistry testing for stages two and three.
20% Performs the formulation of solutions, dilutions of Polyclonal and Monoclonal antibodies, inspection, gel treatment, antibody to gel, and any other related activities required in the preparation of gel card manufacturing ensuring product meets specification. May coach and mentor other associated in these duties. Cleans and maintains critical production equipment and Lab ware
15% Reviews formulation documents to ensure quality and completion. All records are reviewed for completeness and clarity. Complete on time investigation of QERTS events and work with QA to ensure timely lot releases. Participate in OOS investigations and document changes.
5% Perform calibration and maintenance of equipment and make sure that calibration is completed in a timely manner and documents are completed correctly. Order chemicals use in the formulation of solutions and send them for testing to make sure that correct chemicals are used for production
5% Responsible for ordering supplies and parts used in calibration of equipment’s in the Formulation department.
5% Directs activities to ensure that the Formulation department is in a continued state of compliance and inspection readiness.
5% Cleans and maintains critical production equipment and labware
5% Ensure BTR’s and Forms are reviewed for clarity and completeness for timely production release Perform other work-related duties as assigned.

Other Duties:
1. Responsibilities for training designated personnel in departmental procedures; reviews documentation of training for completeness and content; and promoting cGMPs and proper safety and environmental practices.
2. Initiate, write, and revise procedures and specifications as needed.
3. Support projects as part of teams to address area efficiency, production, and equipment improvements. May require creation and approval of protocols and plans.
4. Be an advocate for a safe work environment and be responsible for personal safety and the safety of others. Participate as a member of the site’s EH&S Management Team

Applicants must provide their phone number. Reference job number A3652.