Primary Role:
This individual will work in the Central Quality Assurance sub-group of the Shire Human Genetic Therapies Quality Assurance department. This unit oversees centralized functions which support internal and external GMP operations, such as QC, Supply Chain, Materials Management, Validation, Informational Services, Process Development, etc. This individual will support routine management & coordination of quality systems and policies for cGMP compliant facilities, as well as contribute continuous improvement suggestions and processes to existing quality systems. This position is responsible for successful, timely completion of goals and objectives that strengthen the Quality organization and Shire.
Responsibilities:
The individual may be responsible for, but is not limited to:
Responsible for adhering to GMP regulations, cGMP’s, company policies and values
Execution of policies, processes, procedures and controls to ensure that performance and quality of products conform to established standards and agency guidelines, while looking for ways to continuously improve processes in a compliant manner.
Quality System Management. Including all aspects of deviations, change controls, CAPAs, Investigations, etc. When necessary, revise procedures/policies for compliance and improvement.
Lead investigations for nonconforming raw materials and provide QA support and guidance for QC OOS investigations
Responsible for reviewing and approving Metrology Out of Tolerance reports as well as supporting the Metrology program, as needed
Generation of quality system metrics and development for improvement. Management of daily upper level management updates. Review and approval of documents and production records for GMP compliance. Including, but not limited to: batch records, SOP’s, Validation protocols, QC data and reports, etc.
Perform cell bank batch disposition and review QC data, as necessary
Accountable for meeting functional area goals and objectives as they relate to departmental and HGT goals.
Provide QA support and guidance when representing QA at meetings and on project teams, as required.
Shire is committed to providing high quality, competitive, and appropriate health care benefits for employees and their families.
Shire is an Equal Employment Opportunity and Affirmative Action Employer.
Requirements:
Education & Experience Requirements:
Essential
- Bachelor’s degree in chemistry, biology or a related discipline
- 5-7 years Quality Assurance experience supporting the manufacture of drugs, biologics, or devices.
- A minimum of 5 years relevant experience executing, developing, and/or administrating GMP quality programs in cGMP biotech and/or pharmaceutical environments. With at least 2 years of relevant experience in Quality Assurance, including external auditing experience
- Intermediate to advanced understanding of quality systems and cGMPs.
- Must be flexible.
- Must be able to prioritize and multitask in a challenging environment.
- Excellent interpersonal skills with the ability to communicate well orally and in writing
- Must be able to read, understand, speak, and write (print) legibly in English. desired
- QC knowledge/experience
- Experience as a lead auditor or audit team member.
- Biologics experience
- .Experience with electronic inventory systems (i.e. Ross ERP or SAP), Trackwise, LIMS
Key Skills and Competencies:
- Able to perform functions in accordance with cGMP regulations. Adherence to domestic and international guidelines, company policies and values.
- Knowledge of regulatory requirements and guidelines for US and Europe.
- 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 skills required
- Teamwork skills essential
- Strong organizational skills and detail-oriented a must
- Ability to multi-task in a dynamic environment with changing priorities
- Strong work ethic
Complexity and Problem Solving:
Employee at this level is involved in a variety of tasks of moderate to advanced level scope and complexity; critical thinking/problem solving skills desired Employee receives general instructions on new work; refers to policies and practices for guidance. Work is reviewed, as necessary for technical soundness and accuracy. Responsible for troubleshooting issues related to quality concerns, implementing effective solutions and corrective actions appropriately.
Internal and External Contacts:
Internal
• Quality Control
• Cell Bank CCPD
• Informational Services (IS)
• Pharmaceutical and Analytical Development
• Quality Assurance (US, EU)
• Validation
• Regulatory Affairs
• Supply Chain
• Materials Management (Warehouse, Raw Materials Inventory, Planning, and Purchasing)
• Facilities
• Metrology
External:
• Suppliers: Various raw material and contract testing labs Other Requirements: Must be flexible to work outside of routine business hours on ad-hoc basis. Must be willing to travel (15%)
Apply to Shire
