Sign upLog in

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

TalentBurst, Inc.

Philadelphia, PA

Apply
JOB DETAILS
SKILLS
Administrative Procedures, Analysis Skills, Analytical Development, Change Control, Change Management, Communication Skills, Consulting, Corrective Action, Cross-Functional, Current Good Manufacturing Practice (cGMP), FDA (Food and Drug Administration), GxP, ISO (International Organization for Standardization), Laboratory, Laboratory Equipment, Laboratory Systems, Manufacturing, Operational Audit, Presentation/Verbal Skills, Problem Solving Skills, Procedure Development, Quality Assurance, Quality Control, Quality Metrics, Real-time PCR (qPCR), Regulations, Risk Analysis, Root Cause Analysis, Software Administration, Standard Operating Procedures (SOP), Systems Administration/Management, Systems Engineering, Team Player, Technical Writing, Time Management, Writing Skills
LOCATION
Philadelphia, PA
POSTED
30+ days ago
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.

#TB_PH
#ZRHC

Why TalentBurst?
At TalentBurst, we deliver more than talent, we deliver outcomes. We partner with you to move quickly and connect you to opportunities aligned with your skills and long term growth.

Backed by precision, transparency, and results, we connect top talent with leading organizations through trusted partnerships.

We offer competitive compensation and comprehensive benefits, including medical, dental, vision, and retirement options.

TalentBurst is an equal opportunity employer committed to an inclusive and diverse workforce.

About the Company

T

TalentBurst, Inc.

For over 20 years, TalentBurst Inc. has been an award-winning provider of cutting-edge Workforce Management Solutions. With a strong commitment to staying ahead in the tech landscape, we pioneer innovative approaches to talent acquisition. Our expertise spans Life Sciences, and Healthcare Staffing, Banking, Financial, IT, and Engineering, as well as Global Employer of Record (EOR), Agent of Record (AOR), State, Local Government and Education (SLED), and IC validation/compliance services. Additionally, our division, TalentProcure, leads the industry with offerings such as High Hazard Payroll, Managed Services, and Vendor on Premise (VOP) solutions.

Due to our prioritization of excellent standards, we are Joint Commission Certified and are a certified Minority Business Enterprise (MBE) in the USA and Canada. Supporting over 130 Fortune 500 companies globally, we excel in navigating the landscape of talent acquisition. In a world of constant change, we embrace developing people-centric solutions that address the unique demands of our clients. Stay connected by visiting our website and following us on social media!

 

COMPANY SIZE
5,000 to 9,999 employees
INDUSTRY
Staffing/Employment Agencies
FOUNDED
2002
WEBSITE
http://www.talentburst.com/