Manufacturing Associate - LGC Clinical Diagnostics

ABOUT LGC CLINICAL DIAGNOSTICS:

LGC Clinical Diagnostics develops and manufactures a comprehensive portfolio of catalogue and custom-developed diagnostic quality solutions and component materials for the extended life sciences industry. We partner with IVD assay developers, pharmaceutical, CRO and academic institutions in commercialization activities across the entire diagnostic pipeline. Laboratorians and diagnostic professionals across disciplines of clinical chemistry, immunochemistry, serology, molecular diagnostics, and clinical genomics rely on LGC’s products to support accurate and reliable diagnostic results.

Our operating entities include Maine Standards Company, SeraCare Life Sciences, and Technopath Clinical Diagnostics, which are in vitro diagnostics (IVD) manufacturers of quality measurement tools (calibrators, controls, linearity, EQA/PT, biological materials), the Native Antigen Company, which is a manufacturer and supplier of viral antigens and LGC Proficiency Testing a global leader in PT schemes. We operate FDA-registered and ISO 13485-accredited facilities in Maine (USA), Massachusetts (USA), Maryland (USA), Tipperary (Ireland), ISO 9001-accredited facility in Oxford, UK, and Traverse City, Michigan US.

Each day, our world-class staff, scientific expertise, operational efficiency, and superior quality systems are ready to support the range of advanced technologies that collectively improve patient outcomes - from the widely adopted and established through to cutting-edge NGS and precision diagnostics.

Job Purpose

The Manufacturing Associate provides direct labor for the manufacturing of high-quality diagnostic products using manual and semi-automated equipment and prepares/completes required documentation on manufacturing procedures. This position is responsible for set-up, calibration, and operation of all manufacturing equipment in accordance with cGMP, POPs, SOPs, Safety, and departmental policies. This position utilizes good judgment and critical thinking skills to make operator level decisions regarding the quality of the products manufactured.

Key Responsibilities

Primary

• Prepare products according to approved Manufacturing Process Operating Procedures (POP’s), Standard Operating Procedures (SOP’s), cGMP and ISO 13485 quality systems. 
•  Responsible for performing all manufacturing processes assigned while following all departmental policies (safety) assigned with minimal error.
• Maintain work area in a clean and orderly fashion.
• Promote positive teamwork and continuous improvement ideas

Secondary

• Support additional departments as assigned to cross train and aide the business unit.
• Additional functions, not specifically outlined in this position description as directed by the manager.

Knowledge, Experience and Technical Skills

• Possess a strong work ethic
• Performance driven
• Good organizational skills
• Sharp attention to detail
• Initiative to understand and complete the existing workload with direct supervision.
• Ability to trouble shoot and solve material and process issues with guidance
• Communicate & Collaborate within team for day to day activities.
• Adaptable, with the capacity/flexibility to respond to the demands of a growing/changing company.

Work Environment

The work environment characteristics are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Will operate in biological and chemical manufacturing environments.
• Cleanroom environment
• Weekend and off-hour work to accommodate operations schedule, as needed.

Education and/or Experience

• Preferred 1 to 3 years in a Life Science, cGMP/ISO environment, including clean rooms in a manufacturing department role.
• High School Diploma; Preferred Bachelor’s degree, with a concentration in Biology, Chemistry, or related science
• Basic mathematical skills are required
• Preferred experience with Microsoft Software (Word, Excel, Office).

Physical Demands

The physical demands are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Ability to be on feet for 6-10 hours per day
• Occasional bending, squatting, twisting
• Repetitive task/motions daily
• May occasionally be required to lift and move material weighing up to 50 lbs with appropriate equipment.

ABOUT LGC:

LGC is a leading, global life science tools company, providing mission-critical components and solutions into high-growth application areas across the human healthcare and applied market segments. Its high-quality product portfolio is comprised of mission-critical tools for genomic analysis and for quality assurance applications, which are typically embedded and recurring within our customers’ products and workflows and are valued for their performance, quality, and range. 

OUR VALUES

• PASSION
• CURIOSITY 
• INTEGRITY
• BRILLIANCE
• RESPECT

EQUAL OPPORTUNITIES 

LGC strongly believes that every job applicant and employee should be valued for their individual talents regardless of age, disability, race, color, ethnic or national origin, sex, sexual orientation, gender reassignment, marital or civil partnership, pregnancy or maternity, religion, or belief. Short listing, interviewing and selection will always be carried out without regard to gender, sexual orientation, marital status, color, race, nationality, ethnic or national origins, religion or belief, age, or trade union membership.

For more information about LGC, please visit our website www.lgcgroup.com

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