Manufacturing Associate I

SeraCare Clinical Diagnostics; Milford (MA); On-site; USD 28,000 - 39,000; Full time

Job summary

LGC Clinical Diagnostics is seeking a Manufacturing Associate I in Massachusetts to perform high-quality manufacturing of diagnostic products. You will set up, calibrate, and operate manufacturing equipment in line with cGMP, POPs, SOPs, and ISO 13485 standards.

The role requires strong judgment, math skills, and the ability to stand for long periods. Weekend and off-hour work may be needed to support operations schedule.

Qualifications

• High School Diploma or equivalent required.
• Analytical and critical thinking skills required.
• Ability to stand 6-10 hours per day.
• Experience with Microsoft Office beneficial.

Responsibilities

• Prepare products according to POPs, SOPs, cGMP and ISO 13485.
• Perform manufacturing processes with safety compliance.
• Keep work area clean and promote teamwork.
• Support other departments for cross-training and flexibility.
• May lift and move materials up to 50 lbs as needed.

Skills

Analytical thinking

Critical thinking

Stamina

Mathematical skills

Teamwork

Education

High School Diploma or equivalent

Bachelor’s degree in Biology or Chemistry or related science

Tools

Microsoft Office (Word, Excel)

Automated filling machines

Job description

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.

Company Description

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 Description

Job Purpose

The Manufacturing Associate I applies direct labor for manufacturing high-quality diagnostic products using manual and semi-automated equipment. This role is responsible for setting up, calibrating, and operating all manufacturing equipment in line with cGMP, POPs, SOPs, Safety, and departmental policies. You will use good judgment and critical thinking skills to make operator-level decisions regarding product quality.

Key Responsibilities

• Prepare products according to approved Manufacturing Process Operating Procedures (POP’s), Standard Operating Procedures (SOP’s), cGMP, and ISO 13485 quality systems.
• Perform all assigned manufacturing processes while adhering strictly to departmental safety policies to ensure minimal error.
• Maintain work area in a clean and orderly fashion, promoting a positive teamwork environment and continuously sharing improvement ideas.
• Support other departments as needed to facilitate cross-training and assist the business unit.
• Occasionally be required to lift and move materials weighing up to 50 lbs using appropriate equipment.
• This role may include other tasks not specifically outlined in this position description as directed by the manager.

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.

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

Qualifications

Minimum qualifications

• High School Diploma or equivalent work experience
• Basic mathematical skills are required
• Ability to be on feet for 6-10 hours per day
• Analytical and critical thinking skills are required

Preferred qualifications

• 1 to 3 years in a Life Science, cGMP/ISO environment, including clean rooms in a manufacturing department role.
• Bachelor’s degree or equivalent experience, with a concentration in Biology, Chemistry, or related science
• Experience with Microsoft Office (Word, Excel, Office)
• Experience with automated filling machines

Additional Information

The customary salary range for this position is:

Minimum pay rate: $20 USD per hour

Maximum pay rate: $28 USD per hour

The salary range provided covers the minimum and maximum amounts projected for this role. The base salary will be influenced by factors like experience, skills, and location.

Join LGC and become part of a team that values collaboration, integrity, and brilliance in all we do. We are committed to encouraging a workplace where everyone can thrive and contribute to our mission.

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, parental responsibilities, religion, or belief. Shortlisting, 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.

This position requires current U.S. work authorization. We are unable to sponsor or assume sponsorship for temporary visas (including H‑1B, H‑2B, OPT, O‑1, TN)

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

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