12 days old

Quality Assurance Specialist II- NIGHTS

Shire Human Genetic Therapies, Inc.
Lexington, MA 02421
  • Job Code

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Job Description

Job Description

This position reports to Nights Wednesday- Saturday, 8:00 pm 6:00 am, 10 Hour Shifts.
Primary Duties
  • Routine management & coordination of GMP compliance systems and policies for cGMP compliant facilities.
  • Review and approval of Quality Systems which include deviations and CAPA as well as supporting disposition as appropriate.
  • Collaborates with multiple departments to ensure appropriate RCA and CAPAs have been identified.
  • Monitors policies, processes, procedures and controls ensuring that performance and quality of products conform to established standards and agency guidelines to ensure lasting customer satisfaction.
  • Demonstrate high level of involvement in continuous improvement of quality assurance philosophy and practices to ensure the highest standards are maintained.
  • Examines programs to create efficiencies in practices and optimal utilization of staff. Review of production records for compliance.
  • Assures cGMPs and company procedures are followed and, if needed, procedures/policies are revised.
  • Accountable for meeting functional area goals and objectives as they relate to departmental and company-wide goals.
  • Responsible for adhering to GMP regulations, cGMPs, company policies, and leadership capabilities.

Education and Experience Requirements

  • Essential: A minimum of a B.S. / M. S. degree in science or engineering with at least 2-3 years relevant experience executing and or equivalent work experience, developing, and/or administrating GMP quality programs in cGMP cell therapy/ biotech environments.
  • Knowledge of FDA and EMA regulations and a working knowledge of root cause analysis.
  • Excellent interpersonal skills and the ability to communicate well, orally and in writing.
  • Desired: Direct Cell Therapy / Biologic quality experience within Technical Operations.

Key Skills, Abilities, and Competencies

  • Living our leadership behaviors is a basic expectation for all Takeda employees. Takeda expects all employees to embody the following:
  • Able to perform functions in accordance with cGMP guidelines. Knowledge of regulatory requirements and guidelines for US and Europe.
  • Ability to create, manage and improve complex Quality systems, integrating with existing systems
  • 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, cGMPs, company policies
  • 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.
  • Flexible
  • Strong prioritization and delegation skills
  • Ability to think strategically and tactically, balancing these as workload changes
  • 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 interacts effectively intra- and interdepartmentally to achieve alignment and consensus.
  • Must be capable of defining, implementing, and successfully defending sound QA systems approaches and principles.
  • Open and honest communication, building authentic relations. The individual must be flexible to effectively embrace change.
  • Seeks the input of others before making a decision. Demonstrates personal dedication; balances personal needs with Takedas needs.

Leadership Behaviors

Demonstrates strategic enterprise thinking to find innovative ways to serve patients, and build trust, reputation and business

  • Sees opportunities beyond the scope of own role and influences others to adopt new and effective ways of working

Creates the environment that inspires and enables people to move the organization forward

  • Enables the team to work collaboratively and have challenging discussions.

Focuses on the few priorities that matter most and delivers superior results

  • Creates clarity, fostering alignment and accountability.

Elevates the capabilities of the organization for now and the future

  • Invests time in helping others to enhance their skills and perform at a higher level

Complexity and Problem Solving

  • Employees at this level are involved in a variety of tasks of high level / wide scope and complexity.
  • This individual will be the primary quality assurance representative on multiple Working Teams and is empowered to make strategic Quality Assurance decisions including troubleshooting issues related to quality concerns, implementing effective solutions and corrective actions.
  • It is incumbent upon this individual to bring any concerns to direct supervisor or areas of significant cross- functional disagreement to supervisor.
  • Candidate must be able to perform functions under minimal supervision. Receives general instructions on new work; refers to policies and practices for guidance. Work is reviewed for technical soundness and accuracy.

Internal and External Contacts

  • Contacts are primarily with other professionals in the group (Quality) and QA Operations Floor Support, PTS Investigations, Manufacturing, Facilities / Engineering, Regulatory, Quality Control, Validation and other Technical Services departments.


Other Job Requirements

  • Must be flexible to work late shifts and weekends on an ad-hoc basis, but not common. Would be required for Regulatory inspections and/or critical quality systems.

This job posting excludes CO applicants


USA - MA - Lexington - BIO OPS

Worker Type


Worker Sub-Type


Time Type

Full time

Posted: 2021-06-07 Expires: 2021-07-06
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Quality Assurance Specialist II- NIGHTS

Shire Human Genetic Therapies, Inc.
Lexington, MA 02421

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