The Sr. QA Specialist II will be a senior member of the Quality Assurance team providing support for Tech Transfer QA Operations at the Massachusetts Bio Operations Unit Site. Responsibilities may include, but are not limited to the following:
- Serve as a primary point of contact for Tech Transfer QA Operations Lexington for a given product transferring into or out of the Mass Bio Ops Unit site.
- Partner with QA Operations counterparts to execute technical transfer deliverables.
- Collaborate with cross functional scope owners to progress the Lexington site into a Tech Transfer industry leader.
- Assist in developing routine, standard and efficient processes for technical transfers at the Lexington site.
- Responsible for ensuring escalation/communication pathways are executed with both immediate QA Management and Site leadership teams throughout the project lifecycle.
- Responsibility for adhering to domestic and international GMP regulations, cGMP s, company policies, and leadership behaviors.
- Potential management and oversight of contingent labor.
- QA approver on Tech Transfer Change Controls and other document deliverables.
- QA approver on the creation of and revision to master batch records, formulation preparations, SOPs, Test Methods and other GMP documents.
- QA approver on Quality Systems related to Engineering runs and first in plant manufacturing campaigns
- Attend Tech Transfer Project meetings as primary QA representative.
- Conduct and oversee Risk Assessment activities for new product introductions.
- Support agency and third party audits of the Mass Bio Ops Unit site as necessary.
- Executed Batch Record Reviews for first in plant manufacturing campaigns.
Education and Experience Requirements
- A minimum of a B.S. degree in science or engineering with at least 8 years relevant experience executing, developing, and/or administrating GMP quality programs in cGMP biotech and/or pharmaceutical environments.
- Previous experience working in clinical, commercial and multiproduct facilities.
- Excellent interpersonal skills and the ability to communicate well orally and in writing.
- Previous experience leading risk assessments and associated tools (ex. FMEA).
Key Skills, Abilities, and Competencies
- Able to perform functions in accordance with cGMP guidelines. Knowledge of regulatory requirements and guidelines for US and Europe.
- Previous experience with leading risk assessments utilizing common tools (ex.FMEA).
- Serve a back up to Head of QA Tech transfer for escalation purposes.
- Proficiency with Microsoft applications Word, Excel, Project, and PowerPoint; ability to learn additional software applications, as the need arises.
- Ability to work effectively in a fast-paced environment.
- Strong written and oral communication skills required.
- Good interpersonal skills required.
- Adherence to domestic and international GMP regulations, cGMP s, company policies and leadership capabilities.
- Teamwork skills essential.
- Strong organizational skills.
- Ability to multi-task in a dynamic environment with changing priorities.
- Strong work ethic.
- Ability to meet challenging timelines, in spite of obstacles.
Complexity and Problem Solving
- Employee at this level is involved in a variety of tasks of moderate to high level scope and complexity.
- Candidate receives general instructions on new work; refers to policies and practices for guidance. Work is reviewed for technical soundness and accuracy.
- Responsible for implementing global QA approaches based on sound principles, international industry/regulatory standards, and robust scientific basis.
- Responsible for troubleshooting issues related to quality concerns, implementing effective solutions and corrective actions.
Internal and External Contacts
- Contacts are primarily with other professionals within Takeda and an occasional contact with a CMO or CTL that Takeda has a Quality Technical Agreement in place with.
Notice to Employment / Recruitment Agents:
Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire, a wholly-owned subsidiary of Takeda s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire, a wholly-owned subsidiary of Takeda and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.
Equal Employment Opportunity
Shire, a wholly-owned subsidiary of Takeda, is an Equal Opportunity Employer committed to a diverse workforce. Shire, a wholly-owned subsidiary of Takeda, will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.
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Pay Transparency Policy - https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf
Shire, a wholly-owned subsidiary of Takeda, is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.