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Change Control Specialist

Social Circle, Georgia


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Change Control Specialist

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Job ID SR0046027 Date posted 01/31/2020 Location Social Circle, Georgia

Primary Duties

The position will support the development of a new, state-of-the-art plasma fractionation facility that will bring Takeda additional capacity for fractionation, purification, and fill and finish for its biologic medications.  This position will be responsible for change control implementation within Fractionation and Albumin manufacturing units.


The Change Control Specialist is responsible for managing change controls (CCs) across the lifecycle of the change from development, through implementation, to closure.

Serve as the main point of contact for multiple manufacturing units, including but not limited to:

  • Own multiple CCs in Track-wise (e.g. materials, process, equipment, etc.)
  • Project manage CCs through implementation and closure
  • Ensure appropriate CC assessments are timely completed
  • Coordinate CC implementation with all necessary teams
  • Ensure staff is appropriately trained on changes
  • Ensure documentation meets quality and regulatory compliance standards

Identify and implement improvements targeted at increasing compliance, reducing lead time, and continually improving the change control process.

Serve as Trackwise change control subject matter expert within the manufacturing department and train other Trackwise users with respect to their roles and responsibilities within the change control process.

As per business need, incumbent may be required to support CAPA investigations to adequately identify root cause and implement appropriate corrective and preventative actions to prevent reoccurrence by:

  • Lead problem solving and root-cause analysis sessions
  • Interact with Quality, Engineering and Manufacturing Science units
  • Manage complex investigations using DMAIC tools
  • Ensure effective implementation of corrective and preventive actions

Author and revise GMP documents and manufacturing records (e.g. SOPs, Job Aids, etc.).

Train staff in general manufacturing activities.

Collaborate in the mitigation of any Environmental, Health, and Safety (EHS) needs and risks.

Identify and implement improvement initiatives to improve yield, reliability, and/or process robustness.  This may require leading and implementing change controls.

Demonstrate continuous improvement with respect to increasing job knowledge and proficiency related to the biopharmaceutical industry, as well as technical understanding/problem solving capability

Stay current with biopharmaceutical industry best practices and technologies.

Responsible for organizing data and preparing appropriate documentation including presentation materials for assigned projects.

Education and Experience Requirements

  • Typically requires a Bachelor’s degree in Science, Biotechnology, or Engineering
  • Minimum two years relevant professional (GMP industry) experience
  • Demonstrated ability to perform in a high performing workforce

Key Skills, Abilities, and Competencies

  • Solid GMP background and experience
  • Strong problem solving and analytical skills are required
  • Possess knowledge of core manufacturing principles and support systems
  • Must have excellent organizational, verbal and written communication skills; able to efficiently communicate with cross- functional teams and management on recommended course of action, with minimal assistance.
  • Self-driven individual that requires minimal supervision
  • Must have proficient computer skills and be experienced using MS Office software (Word, Excel and PowerPoint)
  • Experience in Trackwise system if preferred
  • Experience using automation control systems, manufacturing execution systems, and data historians is preferred
  • Knowledge of Lean Six-Sigma methodology is preferred

Complexity and Problem Solving

The Change Control Specialist will facilitate teams in defining the requirements necessary to implement changes within the pharmaceutical industry. The Change Control Specialist will make decisions regarding project management to ensure successful implementation of each change.

Internal and External Contacts

The Change Control Specialist will coordinate cross-functional teams made up of subject matter experts from across the site.  Key customers include quality, regulatory, manufacturing, manufacturing science, automation, engineering, and validation.

Other Job Requirements
  • May occasionally work in a clean-room environment and wear special garments (requires removal of make-up and jewelry)
  • May occasionally wear personal protective equipment (e.g. hard hats, safety shoes, safety glasses, ear plugs) due to safety requirements in specific areas
  • May be required to work weekends, evenings, off-hours, extended periods of time

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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Reasonable Accommodations

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.

Job ID SR0046027

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