Description
The Quality Assurance Professional will work in the US External QA team responsible for Contract Manufacturing (CMO) and Contract Test Laboratories (CTL) oversight within the Biologics Operation Unit Quality Assurance Department . This unit oversees contract manufacturing (3rd party manufacturing) operations of Drug Substance and Drug Products. This unit also provides QA support for Contract testing Laboratories as well as internal Quality Control.
Primary responsibilities include: CMO and CTL QA oversight for the manufacture and testing of commercial biologics products. Interfacing CMO for site compliance documentation, quality systems review (deviations, CAPA, Change control), Supplier Notifications of Change, coordination of executed batch documentation, master batch record review, business management review meetings, APR review, audits, Quality agreement author/reviewer. Interfacing with CTL and internal QC for testing protocol/report review and deviation/CAPA/Change Control review. Other responsibilities include compiling and tracking CMO and CTL metrics, data, and deliverables.
Experience with GMP programs in cGMP biotech and/or pharmaceutical environments. A minimum of 5 years in a cGMP biotech and/or pharmaceutical environment.
Quality experience in Biologics manufacturing and/or Quality Control knowledge, required. Previous experience in other Quality Assurance functions is a plus. Excellent interpersonal skills and the ability to communicate well orally and in writing. Strong business acumen (Operations, productivity, continuous improvements). Must be flexible. Must be able to prioritize with minimal supervision.
Good interpersonal and teamwork skills required. Strong organizational skills and detail oriented a must. Ability to multi-task in a dynamic environment with changing priorities. Strong work ethic.
All your information will be kept confidential according to EEO guidelines.
#J-18808-Ljbffr...Administrative Assistant - DFTL - 0282 Greenspoon Marder LLP Fort Lauderdale, FL Salary: $80,000.00$92,000.00 Qualifications... ...religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law. All...
...Description Job Description TITLE: SALES MANAGER GROUP & EVENTS (Hospitality & Live Entertainment Venue) LOCATION : Houston... ...elevated food and beverage, and curated guest experiences in a multi-level venue featuring private dining and event spaces. The...
...Job Description Job Description The Auto Parts Delivery Driver drives company vehicles to pick up and deliver parts in the local area. He or she transports products from local parts sources and delivers them to our dealership. Most importantly and without exception...
...Federal Express Corporation (FEC) is part of the rapidly growing warehouse and transportation sector that helps keep America, and our... ...employment! ~ Generous paid time off program - work your way up to 5 weeks of PTO a year! ~ Medical, dental and vision benefits...
...Interventional Pain Management Physician Panama City FL $415k-$460k to start with potential up to $575k We are looking for an Interventional Physical Medicine and Rehabilitation/Anesthesiologist Physician (PM&R) to join our growing medical team full time...