• 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 the Functional Manager
• Supporting QC and GxP Systems in regulatory inspections, as assigned by the 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, and 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.
• 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.

The hiring range for this position is $40 to $46 per hour. The base pay actually offered will take into account internal equity, and may also vary depending on candidate's geographic region, job-related knowledge, skills, and experience amongst other factors

Harvest Technical Services is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, Sexual orientation, national origin, genetics, pregnancy, disability, age, veteran status, or any other federal, state, or local protected class.