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.
Job details are sourced from the employer's original posting.
Open job postingAbout the company
Established in 2000, A Minority Business Enterprise (MBE), LanceSoft Inc. is a pioneer in providing premium end-to-end Professional IT/Non-IT Contingent Workforce Solutions and IT Services to diverse clients across various domains. Core Service Offerings We offer a gamut of services across diverse domains, categories, skill sets with varying lengths of assignments, that include, but are not just limited to: - Temporary Staffing - Permanent Staffing - Payrolling - Recruitment Process Outsourcing (RPO) - Back-office Services - Application Design and Development - Website Design and Development - Program/Project Management Our Domain Strength With currently over 1000+ staff serving over 49 clients worldwide including “Fortune” companies, LanceSoft serves a wide array of industries including Healthcare/Pharma, Clinical/Medical Devices, Technology, Telecom, Retail and Distribution, Energy & Utilities, Banking, Finance, Insurance, Manufacturing, Automobile, Media, Transportation, and Government Sectors. Geographic Coverage LanceSoft is headquartered in Herndon, Virginia and has a network of branch offices across the US in Chicago (IL), Irving (TX), Basking Ridge (NJ), Atlanta (GA) and San Diego (CA). We also have an International footprint with two country offices in Canada (ON and BC) along with three delivery centers in India- Bangalore, Indore and Hyderabad to further help serve our clients better. We currently operate and recruit in 49 US states catering to diverse Contingent Workforce needs of our clients. Awards and Accolades Following are some of our awards and accolades in the US Contingent Workforce space: - Manpower “Premier Vendor” – 2014 - Kelly’s “Supplier Innovation Award” – 2012 - Kelly’s “Supplier of the Year” Award – 2012 and 2011 - Kelly’s “Service Excellence Award” – 2010 and 2009 - “Stewardship Recognition” from Johnson & Johnson’s (J&J) Kelly Work sense program Specialties IT/Non-IT Contingent Workforce Services, Creative Solutions, Temporary/Permanent Staffing, Recruitment Process Outsourcing, Payrolling, Application Design and Development, Back-office Services, Program/Project Management, Website Design and Development