Job Type: Contract
Length: 6 months (renewable)
The Quality Assurance Professional will work in the US External QA team of Shire Human Genetic Therapies Quality Assurance Department. This unit oversees contract manufacturing (3rd party manufacturing) operations, packaging & labeling operations (external and internal), internal warehouse operations, and logistics performed on behalf of Shire. This unit also provides QA support for Quality Control (drug product testing and stability) and Pharmaceutical Analytical Development (PAD) operations. This position provides support to the Quality Control unit including Commercial (Internal & External), Development QC Operations and Analytical Development.
Responsibilities include support of Commercial QC Operations: QC data review and approval. Raw material QA support. Stability and trending reports review and approval. Laboratory Operations support. QC Labs compliance assessments. SOP review and approval Quality systems (Deviations, OOS, CAPA,) tracking and review. Provide support for Development QC testing and Pharmaceutical Analytical Development.
BS with 0-5 years of relevant QA experience. Understanding of USP and EP. Experience with GMP programs in cGMP biotech and/or pharmaceutical environments. 2 years in a cGMP biotech and/or pharmaceutical environment is desired. Quality Control knowledge, previous experience in QC a plus. 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. Fluency in English is required.
Desired: Quality experience in parenteral biotech manufacturing (aseptic or sterile processing). Quality experience in drug substance manufacturing. Able to perform functions in accordance with cGMP regulations. Adherence to domestic and international guidelines, company policies and values. Proficiency with Microsoft applications Outlook, Word, Excel, Project, and Powerpoint; ability to learn additional software applications as the need arises. Strong written and oral communication skills required. 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. Proactively addressing compliance issues and assuming responsibility for compliance deficiencies. Proficiency with Microsoft applications Word, Excel, Project, and Powerpoint; ability to learn additional software applications, as the need arises. Ability to multi-task in a dynamic environment with changing priorities. Ability to meet challenging timelines, in spite of obstacles, within budget. Strong written and oral communication skills required. Excellent interpersonal skills required. Adherence to domestic and international GMP regulations, cGMPs, company policies, performance management and department budget. Teamwork skills essential. Strong organizational skills. Strong work ethic and flexible. Strong prioritization. Self-motivated and driven to independently accomplish department goals and objectives. Positive outlook and motivating, in spite of obstacles. Understands the needs of key collaborators and customers, and interact effectively intra- and interdepartmentally to achieve alignment and consensus. Internal: Quality Control; Supply Chain/ Global Logistics; Regulatory Affairs; Pharmaceutical Development; External Manufacturing. Ability to work during routine business hours. Key Leadership Capabilities: Delivering Excellence; Building Authentic Relationships