Please note this position is an 18 Month Contract position and is Onsite.
Please note that this position requires Pharma Background.
Top Skills:
· Really need to have Quality Control experience
· Must have at least 2 years of experience
· Role is a QC Lab Services Analyst
· Must have experience with Manufacturing and Quality Control
· Must have experience with equipment qualifications
· Will do qualification of analytical equipment (related to HPLC, Endotoxin, Cell Culture)
· Must have a Pharma background
· Must know GMP regulations
· Experience with eLIMS
· Experience with writing SOPs and drafting protocols
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
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 Biotherapeutics Manufacturing facility in Wilson, North Carolina (BioNC). 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
Candidates must provide their phone number. Job reference number is A5664.
