Job opening for QC Lead Investigator/Event Owner (Laboratory Equipment)

Job Title: QC Lead Investigator/Event Owner (Laboratory Equipment)
Location: 3025 market street Philadelphia PA 19104
Duration: 12 Months
Position Type: Contract / Consultant
This is for the Spark location in Philadelphia PA.
Hours requirement: 8 to 5; may need to have some flexibility to work earlier/late as needed

Laboratory equipment or laboratory software troubleshooting
Understanding of validated equipment states
Ownership of equipment or system investigations
Knowledge of configuration specifications, user requirements specifications, system qualification documents, and equipment administration procedures

The Quality Control (QC) team is seeking a laboratory equipment 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 procedures focused on QC Laboratory Equipment.

The individual in the role will be responsible for, but not limited to, the following tasks:

• 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.
• System administrator of QC Lab Equipment
• 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.
• This position requires good written and verbal communication skills and the ability to work effectively in a team environment is a must.

Job Function and Description

• Conduct comprehensive laboratory equipment investigations, deviations,cquality 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.
• Collaborating with QC, Lab Systems Engineers, and Quality Assurance
• Use of Lab Equipment/Systems/Software (Empower, Qx Manager, LabX, Softmax, qPCR, etc)
• Update SOPs, Protocols, supporting documents as needed.

Education and Experience Requirements
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 Lab Equipment/Systems/Software (Empower, Qx Manager,
LabX, Softmax, qPCR, etc.)

Key Skills, Abilities, and Competencies
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
Experience in technical writing.
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.
Complexity and Problem Solving
Discuss investigational findings and/or root cause with senior members of team and
refer to SOPs/policies for guidance.
Exercise judgment within defined procedures and practices to determine appropriate
action.
Must be comfortable in the fast-paced, biotech environment and interact with multi-
disciplinary teams
Internal and External Contacts
Quality Control (QC) Team Members
GxP Systems Team Members
Quality Assurance (QA)
Information Technology (IT)
Cross-functional Team Members across Analytical Development and Technical
Development organizations
Other Job Requirements
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.

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