Lab Technician

Summary: Responsible for performing manufacturing and assembly of clinical and commercial products. Weighs, measures, and checks raw materials and/or manufacturing parts to assure that batches manufactured contain proper ingredients and quantities. Participates in the filling, aliquoting, and packaging of bulk material into the final product.

Primary Responsibilities:

• Handling and traying of temperature-sensitive (semi-)finished goods for use in blood screening kits

• Perform inprocess visual inspection of temperature-sensitive (semi-)finished goods for use in blood screening kits as they come off the fill line before placement in trays.

• Perform sample gathering of temperature-sensitive (semi-)finished goods for use in blood screening kits for QC and Bio-burden.

• Receives and verifies the accuracy of materials transferred from the warehouse.

• Assists with material handling, folding product boxes/trays and staging of materials for process orders

• Understands and executes written procedures in accordance with cGMP.

• Performs labor transactions in the Enterprise Resource Planning (ERP) System.

• Maintains detailed and accurate device history records with cGMP and forwards them in a timely manner for review.

• General manufacturing area housekeeping including cleaning of labware, equipment, totes, shelves, benches and sinks and removing trash.

• Ensures proper transportation, handling, and disposal of hazardous, bio-hazardous and/or infectious substances.

• Maintains accurate and complete training records.

• Maintains and archives Manufacturing log sheet records.

• Demonstrate processes during audits, including ISO, FDA and internal audits.

• Follows all safety rules.

• Must be able to communicate product issues, safety incidences and/or personal issues affecting production timelines.

• Verify or perform cycle counts and verify discrepancy, conduct investigation and complete report to notify lead ·

• Independently perform and lead the set-up and operation of reagent filling equipment of at least 70% of automated fill machines

• Perform equipment troubleshooting during operation to ensure completion within the scheduled time frame

• Assist with training and mentoring

• Primary contact for material transfer delegation

• Participate in the execution of process improvement projects

• Implement new areas or ideas for 5S -

Quality notification (QN) investigations: provide information to the quality notification author to complete the quality notification investigation. Education: Requires Associates Degree in Biology, Mechanics, Engineering or related field.

Experience: 6 years minimum experience as a reagent fill technician or equivalent in a regulated setting. 2 years experience troubleshooting fill equipment. 7 years minimum experience in a lab setting is highly preferred.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent

• Maintaining an inclusive environment through persistent self-reflection

• Building a culture of care, engagement, and recognition with clear outcomes

• Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.