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QuidelOrtho · 1 day ago

Serologist I

US - FL - Pompano Beach

Full-time

Onsite

Entry Level

1+ years exp

QuidelOrtho is a leading in vitro diagnostics company focused on transforming the power of diagnostics into a healthier future. The Serologist I will support Immunohematology products by testing raw materials and ensuring compliance with company standards and regulatory agencies while participating in failure investigations and suggesting process improvements.

Medical Device

Responsibilities

Performing all manufacturing processes in accordance with GMP’s, SOP’s, TMs, safety rules and production schedule. Use current documentation system as required

Troubleshoot operational problems

Works in an environment with ever-changing priorities

Maintains accurate, complete and timely written batch records and documentation

Perform batch record review of documents as needed

Perform ERP transactions to ensure inventory is accurate. Perform cycle counts and special counts in a timely manner. Assure all raw materials are on-hand as needed for manufacturing processes

Participate in group’s compliance efforts regarding safety regulations and requirements including cGMPs, OSHA, Universal Precautions and Product License Agreements

Clean and maintain production areas and equipment according to procedures. Ensure equipment maintenance programs are followed, equipment is calibrated and scheduled preventative maintenance is performed when required

Performs additional work-related duties as assigned

Qualification

CGMP experienceMedical Technology degreeMicrosoft Office proficiencyFDA regulations familiarityManual dexterityTroubleshooting knowledgeCommunication skillsInterpersonal skillsAttention to detail

Required

Bachelor's degree in Medical Technology, Biology or a related field of study and a minimum of 1-3 years' experience within a cGMP environment

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)

Preferred

Familiarity with the guidelines and regulations of FDA, OSHA, ISO and cGMP

Good understanding of products and processes

Strong mechanical and troubleshooting knowledge within area

Attention to detail, documentation accurate and neat, must be very organized

Interpersonal skills to include working independently or with a team member

Excellent communication skills, both written and verbal

Demonstrate training progression through assigned curriculum

Company

QuidelOrtho

Glassdoor3.5

> Bringing precision and passion in everything we do QuidelOrtho stands at the forefront of testing, tracking and disease analysis of health conditions ranging from HIV and hepatitis C to flu, strep and COVID-19.

Founded in 1937

5001-10000 employees