Quality Control Senior Associate

Spectraforce Technologies, Inc.

Holly Springs (NC)

On-site

USD 65,000 - 90,000

Full time

3 days ago
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Job summary

Spectraforce Technologies, Inc. seeks a Quality Control Senior Associate for 100% on-site work at our Holly Springs, NC facility. The role focuses on writing, owning, and driving closure of quality records, including deviations, CAPAs, and change controls.

The candidate should have GMP experience and strong investigative leadership. Ideal candidates will collaborate with cross-functional teams, lead investigations, and support startup activities in a GMP QC laboratory.

Qualifications

  • Must have GMP/regulatory quality experience.
  • Ability to own and drive closure of quality records (deviations, CAPAs, change controls).
  • Strong written communication and investigative leadership.

Responsibilities

  • Author and own change control records and deviations in the DQMS Veeva System.
  • Lead investigation teams and report metrics for the systems group.

Skills

GMP
Deviation investigation
Equipment qualification

Education

High school diploma or GED
Associates degree
Bachelor's degree

Tools

DQMS Veeva System

Job description

Job Title: Quality Control Senior Associate

Duration: 12+ Months (Possible extension)

Location

Holly Springs, NC 27540 (Onsite)

Description

This role is 100% on-site at the Holly Springs, NC facility, working a standard weekday schedule (8am-5pm) with some flexibility (start between 7-9am).

Pref. Local candidate

The ideal candidate will bring at least 3 year of industry experience within a GMP-regulated biotech or pharmaceutical environment. They must demonstrate strong knowledge of quality systems and QC laboratory operations with a proven ability to write, own, and drive closure of quality records, including deviations, CAPAs, and change controls.

This role requires excellent written communication, grammar, and investigative leadership skills. Candidates should be detail-oriented, proactive, and able to navigate shifting priorities in a fast-paced environment with minimal oversight. They will collaborate with multiple cross-functional teams and should be confident leading meetings and pushing investigations independently through to completion.

Experience with Veeva Quality Systems is highly desirable.

This position will be part of the Quality Control Deviation and Change Control team for start up and operations of the ANC facility.

  • Working collaboratively with Quality and Quality Assurance teams to author and own change control records and deviations in the DQMS Veeva System
  • Individual will lead investigation teams and help to collect and report metrics for the systems team
  • Support the startup of a GMP QC laboratory.
  • Support routine activities over the weekends and public holidays as required.
Basic Qualifications

High school/GED + 2 years work experience OR

Associates and 6 months work experience OR

Bachelors

Top 3 Must Have Skill Sets

GMP; Deviation investigation; Equipment qualification

Day to Day Responsibilities
  • Working collaboratively with Quality and Quality Assurance teams to author and own change control records and deviations in the DQMS Veeva System
  • Individual will lead investigation teams and help to collect and report metrics for the systems team
Possible Extension

Yes

Red Flags

No QC experience

Interview Process

one Team's interview

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