QC Lab Services Analyst

Job Description

Job Description:

• We are currently seeking a highly qualified individual to join our team as a QC Lab Services Analyst (Analytical Instrument and Lab Systems) at our new facility in Wilson, North Carolina.
• In this key role, you will be responsible for laboratory equipment lifecycle management and CSV support, among others.
• 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.

Essential Job Duties and Responsibilities:

• Participate in the qualification of analytical equipment for related testing functions, for example, IQ/OQ/PQ of HPLC, Spectrophotometry, Endotoxin, Cell Culture and Total Organic Carbon equipment.
• Author SOP’s, Work Instructions and protocols.
• Responsible for the quality control laboratory equipment lifecycle management and CSV support.
• Participate in activities to introduce technologies and computer base applications to a new site, for example eLIMS/iLABS, SDMS, Empower and SoftMax Pro, SAP, to improve laboratory efficiency and promote a culture of Innovation.
• Interact with the QC Global organization for the different center of excellence for equipment and information technologies.
• The resolution of unexpected complex compliance or lab instrument and system issues as they arise

Qualifications:

• Bachelor’s Degree in Chemistry, Biochemistry, Micro or science related field with 2+ years related experience in biopharmaceutical or pharmaceutical industry. And/or an equivalent combination of education and experience.
• Working knowledge of regulatory requirements, policies and guidelines. Experience with Quality Control document reviews and regulatory inspection processes.
• Working knowledge of laboratory systems.
• Strong technical knowledge in and experience with QC analytical equipment is required.
• Knowledge of cGMP regulations and FDA/EU guidance is required.

Other Requirements:

• An unquestionable level of integrity and commitment to operating ethically and within the boundaries of regulatory requirements.
• Excellent communication and interpersonal skills, with the ability to effectively collaborate 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.
• Detail-oriented mindset, with a keen eye for identifying opportunities for process improvements.
• Proven ability to prioritize tasks and meet deadlines in a dynamic manufacturing environment.
• The ability to work in a team environment and interact with all levels of the organization.
• What would you consider to be the top three non-negotiable skills that you would be looking for when reviewing candidate resumes? Equipment Lifecycle Management, cGMP experience, Document Authorship