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Specialist, QC - United States
Posted on : 28 May 2017
- Our company is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases.
- We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children.
- These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options.
- Our company will continue to focus on advancing therapies that are the first or best of their kind.
- Our company’s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market.
- These engineers, technicians, scientists and support staff build and maintain our company’s cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients. Come join our team and make a meaningful impact on patients’ lives.
This position reports to the Manager of Quality Control Contract Laboratory Management and will assist with the management of QC contract testing and cell bank production related activities. Key responsibilities includes:
- Provide support in organizing QC contract testing and cell bank production activities.
- Provide assistance in the maintenance of on-site and off-site cell banks.
- Establish effective communication and collaborative relationships with other functional groups, key stakeholders, and external contacts.
- Maintain databases of contract testing lab activities and information.
- Organize and track contract testing and cell bank testing/production activities.
- Develop modules of QC contracted assays.
- May generate and/or revise Quality Technical Agreements with contract testing labs and contract cell bank manufacturers.
- Maintain databases for tracking of contract laboratory testing and/or cell bank activities.
- Generate legal contract requests and purchase orders for contract testing and cell bank testing/production.
- Initiate change requests (CR) for new cell bank production and SOP revisions using TrackWise system.
- Create and maintain cell bank binders for cell bank production and testing activities.
- Perform log-based cell bank inventories.
- Perform on-site physical cell bank inventories.
- Request and coordinate cell bank vial shipments to/from offsite biorepository.
- Assist with shipment of samples and reagents to contract labs.
- Manage and maintain good relationships with contract testing lab partners.
- Support regulatory filings.
- Support regulatory agency, partner and QP inspections.
QC Specialist in the QC Contract Laboratory Management group provides system support in the QC contract testing and contract cell bank production functions, as applicable to our company's commercial biologics and pharmaceutical products.
B.S./B.A. degree with 2-4 years of experience in pharmaceutical industry, including some work in a laboratory setting. Thorough knowledge of cGMPs and regulations applicable to the FDA and comparable international regulatory agencies. Good written and verbal communication skills.
- At least 2-4 years in a cGMP laboratory; quality control experience preferred.
- Experience in dealing with contract testing laboratories is preferred.
- Well-developed laboratory skills for analysis of pharmaceuticals and biopharmaceuticals.
- Demonstrated ability to perform most tasks with minimal supervision given general instructions on routine work and detailed instructions on new assignments.
- Proficiency in MS Excel, MS Word, and MS PowerPoint.
- Knowledgeable and conversant concerning 21CFR, USP, EP, and ICH regulatory guidelines.
- Contract testing labs/Vendors
- QC Management and personnel
- Quality Assurance
- GxP Compliance
- Enterprise Applications
- Manufacturing Sciences
- Process Development/Process Sciences
- Regulatory Affairs
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.