Quality Control Technician

Spectraforce Technologies; Worcester (MA); On-site; USD 45,000 - 65,000; Full time

Job summary

Spectraforce Technologies in Worcester, MA is seeking a Quality Control Technician. The role performs sample retain/discard per GMP and conducts Environmental Monitoring testing in a GMP setting, including during fill operations.

Training occurs Mon-Fri for 6-12 weeks, then a split weekend schedule as described, with typical 8:30 AM - 4:30 PM hours. Requires a BS in Biology or life sciences and hands-on QC micro experience, aseptic technique, and biosafety hood experience.

Qualifications

• BS in Biology or another life science field.
• Hands-on QC micro experience in a GMP environment.
• Hands-on aseptic technique experience.
• Experience with biosafety hoods.
• Attention to detail with careful lab data management.
• Knowledge of GMP documentation and record keeping.
• Strong interpersonal and communication skills.
• Familiarity with LIMS and regulatory standards (USP/ICH) is preferred.

Responsibilities

• Performs sample retain discard per GMP procedures.
• Performs routine Environmental Monitoring testing.
• Performs Environmental Monitoring during a fill operation.
• Supports other lab testing and product/material release.
• Documents results and maintains GMP-compliant records.
• Assists with trend data and weekly reports.
• Works with supervision but manages time to meet schedule.
• Willingness to work weekends/holidays.

Skills

Attention to detail

Interpersonal skills

GMP awareness

LIMS familiarity

Prioritization

Education

BS in Biology or life science

Tools

LIMS system

Job description

Position Details

Position Title: Quality Control Technician

Work Location: Worcester, MA 01604

Assignment Duration: 12 Months (possible extension - performance based)

Work Schedule

• Training: Monday-Friday for the first 6-12 weeks, 8:30 AM - 4:30 PM
• Post-Training: One position will work Sunday-Wednesday and the other will work Wednesday-Saturday, generally 8:30 AM - 4:30 PM

Position Summary

The Primary function would be to : Performs sample retain discard per GMP procedures. Performs routine Environmental Monitoring testing within a GMP environment.

Key Responsibilities

• Performs sample retain discard per GMP procedures.
• Performs routine Environmental Monitoring testing within a GMP environment.
• Performs Environmental Monitoring (EM) during a fill operation.
• Supports other lab associated functions. Perform test methods as written to support product/material release. Effectively perform a multitude of laboratory techniques with minimal error for which they will be trained on.
• Understand, implement, and maintain GMP with respect to laboratory records, procedures, and systems in accordance with procedural requirements.
• Accept responsibility to complete assigned tasks as committed.
• Support investigation writers and approvers to gather data. effectively perform a multitude of laboratory techniques with minimal error for which they are or will be trained on
• Writes or revises procedures with guidance.
• Works under the guidance of a supervisor but is able to manage their own time to ensure timely completion of assigned duties
• Trends data to support trend reports.
• Should be willing to work on weekends and holidays.

Qualification & Experience

• BS in Biology or other life science required
• QC Micro experience- -Hands- on experience with lab testing and EM.
• hands- on Aseptic Technique experience preferable.
• hands- on working experience in Biosafety hoods preferable.
• Attention to detail while running assays/ tasks in the lab and while performing EM is required
• Should have good organizational skills, ability to prioritize workload and extremely thorough with excellent attention to detail.
• Should perform tasks with supervision guidance, taking responsibility for complying with GMP requirements.
• Strong interpersonal / communication skills. Maintaining good working relationships within and outside the department.
• Adjusting quickly to new situations. Reprioritizing to meet schedule demands in continually changing work environment.
• Knowledge with the LIMS system, specifically entering results is preferred * Knowledge of applicable regulations and standards affecting Pharmaceutical Products (e.g. USP, EP, JP pharmacopoeias, ICH guidelines, cGMP) is preferred.
• GMP and/or Clean-Room experience * Clean-Room Gowning.
• Experience with cGMP documentation and record maintenance is required.