QC Equipment Lifecycle Specialist

Spectraforce Technologies; Harvard (MA); In loco; USD 70.000 - 105.000; Tempo pieno

Descrizione del lavoro

Spectraforce Technologies, Inc. in Devens, MA seeks a QC Equipment Lifecycle Specialist to support validation, calibration, and maintenance of QC laboratory equipment in a GMP setting. The role interfaces with QC SMEs, site engineering, facilities, and vendors for lifecycle activities and procedure updates.

The specialist will maintain records, assist investigations, and ensure data integrity and compliance across analytical and microbiology QC labs.

Competenze

• Experience in GMP environments with instrument qualification.
• Ability to understand and apply global GMP requirements accurately.
• Detail-oriented with strong problem solving.
• Ability to work independently in a fast-paced team.
• Strong written and verbal communication with cross-functional peers.
• Working knowledge of biomolecular equipment is preferred.
• 2+ years of relevant regulated-ex environment experience.

Mansioni

• Collaborate with QC labs and other departments to validate, calibrate, maintain QC equipment.
• Maintain equipment records per GMP procedures.
• Keep electronic equipment database and logs up to date.
• Assist management with investigations and deviations related to equipment.
• Perform tasks to support QC laboratories as required.

Conoscenze

GMP compliance

Documentation

Regulatory knowledge

Communication

Problem solving

Independent work

Lab equipment knowledge

Formazione

Bachelor's degree in chemistry/microbiology

Strumenti

PCR

BSCs

Plate reader

Descrizione del lavoro

Job Title: QC Equipment Lifecycle Specialist

Job Location: Devens, MA 01434

Job Duration: 12 Months assignment (possibility of extension)

Shift: Mon-Fri: Working Hours - 8am - 5pm,

(A potential opportunity for remotely working, maybe 1 day a week remote however given the nature of the job, expectation will be on-site majority of the days)

Training will be on-site, not remotely

The Specialist role is stationed in Devens, MA and reports to the Sr. Manager of QC LIMS and Equipment.

Job Summary:

The client is seeking a Specialist, QC Equipment Lifecycle Management, at Cell Therapy Facility (CTF) in Devens, MA. The QC Specialist will support equipment validation, calibration, and maintenance within analytical and microbiology QC laboratories. This includes, but is not limited to,

• Interfacing with QC laboratory SMEs, Site Engineering, Facilities, and vendors to facilitate equipment lifecycle management activities and procedure revisions

Job Responsibilities:

• Collaborate with QC laboratories, Site Engineering, Facility Services and other departments, participate in performing the validation, calibration, maintenance, repairs of QC laboratory equipment.
• Maintain equipment records in accordance with GMP requirements and written procedures.
• Maintain electronic equipment database, equipment logs, equipment status metrics, and applying equipment status labels.
• Assisting management with investigations and deviations related to equipment.
• Performs other tasks as required to support the QC laboratories.

Qualifications and Education Requirements

• Experience in computers and enterprise applications and instrument qualification in GMP environment.
• Ability to understand, follow, and apply global regulatory and GMP requirements accurately and completely.
• Detail-oriented with expertise in problem solving abilities.
• Ability to work independently in a high-paced team environment, meet deadlines, and prioritize work from multiple projects.
• Strong written and verbal communications skills and interpersonal skills; Ability to communicate effectively with peers, department management and cross-functional peers
• Working knowledge of Biomolecular, Analytical and Microbiology laboratory equipment such as PCR, BSCs, Plate reader, etc. is desired.
• Working knowledge of Data Integrity is desired.
• Bachelor's degree required, preferably in chemistry, microbiology, or related science.
• 2+ years of relevant experience, preferably in a regulated environment, is highly desired.
• An equivalent combination of education and experience may substitute.