QC Lead Investigator\/Event Owner (Laboratory Equipment)

Job Description

Position Title:

QC Lead Investigator\/Event Owner (Laboratory Equipment)

Work Location:

Philadelphia, PA, 19104

Assignment Duration:

12 Months

Work Schedule:

8 AM to 5 PM (flexibility for earlier or later hours as needed)

Work Arrangement:

Onsite (majority ~80% of time with lab activities, PPE required)

Position Summary:

The Quality Control (QC) team is seeking a lead investigator. The position is responsible for conducting comprehensive investigations, deviations, change controls and CAPAs for the Quality Control Department in accordance with cGMPs, international regulations, and The Organization's procedures.

Key Responsibilities:

• Collaborating with QC, Lab Systems Engineers, and Quality Assurance to conduct comprehensive laboratory equipment investigations, deviations, quality incidents, change controls, and CAPAs while ensuring timely completion.
• Support implementation of relevant corrective and preventive actions.
• Perform risk and impact assessments for QC Operations as assigned by Functional Manager
• Supporting QC and GxP Systems in regulatory inspections, as assigned by Functional Manager.
• Maintain good documentation practices.
• Comply with all SOPs, policies, and laboratory safety procedures.
• Conduct comprehensive laboratory equipment investigations, deviations, quality incidents
• Identify and implement Corrective and Preventative Actions (CAPAs)
• Write and manage change controls for the implementation of new laboratory equipment, systems, and software.
• Perform laboratory system administrator actions such as user account creation, template creation, method locking, etc.
• Use of Lab Equipment/Systems/Software (Empower, Qx Manager, LabX, Softmax, qPCR, etc)
• Update SOPs, Protocols, supporting documents as needed.

Qualification & Experience:

• Bachelor's degree in a scientific, engineering, or quality-related field (or equivalent experience).
• Proven experience in Quality Control, Quality Assurance, or a related role in manufacturing or regulated industries.
• Preferred experience with deviations, change controls, and CAPAs technical writing.
• Strong knowledge of quality standards, regulations, and processes (e.g., FDA, ISO, GMP).
• Experience with root cause analysis techniques such as 5 Whys, Fishbone diagrams, and FMEA.
• Proficiency in Veeva Vault QMS
• Excellent problem-solving and analytical skills.
• Proficient in maintaining detailed, accurate, and organized documentation.
• Strong verbal and written communication skills, with the ability to communicate effectively at all organizational levels.
• Ability to work collaboratively with cross-functional teams.

Working Conditions & Physical Demands (If Applicable): Position is an office-based role with lab-based activities and therefore requires the candidate to be on site the majority (>80%) of time and to wear PPE as required by lab SOPs. Applicant Notices & Disclaimers For information on benefits, equal opportunity employment, and location-specific applicant notices, click here At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position's starting pay is: $41.00/hr.