Senior QC Associate (Temporary) - United States
- 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.
- This position will assist with the management of QC contract testing and cell bank production related activities.
Key responsibilities may include:
- Provide support in organizing QC contract testing and cell bank production activities.
- Provide support in coordination of international shipments.
- Liaise between contract laboratories and internal company groups.
- Assist with management of in-country testing and provide updates to team and management.
- Establish effective communication and collaborative relationships with other functional groups, key stakeholders, and external contacts.
- Maintain tracking spreadsheets/databases for contract testing lab activities and information.
- Organize and track contract testing and cell bank testing/production activities.
- May generate and/or revise Quality Technical Agreements with contract testing labs and contract cell bank manufacturers.
- 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.
- Perform log-based 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.
- At least 4 years in a cGMP laboratory; quality control experience required.
- Experience in dealing with contract testing laboratories is highly 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 Applications
- Excellent organizational and project management skills.
- Knowledgeable and conversant concerning 21CFR, USP, EP, and ICH regulatory guidelines.
- B.S./B.A. degree with 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.
- Excellent written and verbal communication skills