QC Lab Services Analyst

Kelly, in partnership with Johnson & Johnson, is hiring a QC Lab Services Analyst

Description:

We are seeking a highly qualified individual to join our team as a QC Lab Services Analyst (Analytical Instrument and Lab Systems) at our new Biotherapeutics Manufacturing facility in Wilson, North Carolina (BioNC). In this key role, you will support laboratory equipment lifecycle management and computer system validation (CSV), among other responsibilities.

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Key responsibilities include, but are not limited to:

• Participate in the qualification of analytical equipment used for testing, including IQ/OQ/PQ for HPLC, spectrophotometry, endotoxin, cell culture, and total organic carbon equipment.

• Author SOPs, work instructions, and protocols.

• Support quality control laboratory equipment lifecycle management and CSV activities.

• Participate in the introduction of technologies and computer-based applications at a new site, such as eLIMS/iLABS, SDMS, Empower, SoftMax Pro, and SAP, to improve laboratory efficiency and promote a culture of innovation.

• Collaborate with the QC Global organization and its centers of excellence for equipment and information technologies.

• Resolve complex compliance, laboratory instrument, and system issues as they arise.

Required Skills and Experience:

• Bachelor’s degree in chemistry, biochemistry, microbiology, or a related scientific field.

• A minimum of two years of related experience in the biopharmaceutical or pharmaceutical industry.

• Experience reviewing Quality Control documents and supporting regulatory inspection processes.

• Working knowledge of regulatory requirements, policies, and guidelines.

• Working knowledge of laboratory systems.

• Strong technical knowledge of and experience with QC analytical equipment.

• Knowledge of cGMP regulations and FDA and EU guidance.

Preferred Skills and Experience:

• Unquestionable integrity and a commitment to operating ethically and in accordance with regulatory requirements.

• Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams and communicate complex quality concepts to stakeholders at all levels.

• Proven ability to manage multiple priorities and work independently with minimal supervision.

• A detail-oriented mindset and a keen eye for identifying process improvement opportunities.

• Proven ability to prioritize tasks and meet deadlines in a dynamic manufacturing environment.

• Ability to work in a team environment and interact with people at all levels of the organization.