Posted to MedZilla on 1/16/2019

Takeda Pharmaceuticals

US-IL, Quality Auditor (Remote - Nationwide) SR0031098-MZ


Takeda is an industry-leading, global pharmaceutical company with an unwavering dedication to putting patients at the center of everything we do. We live our values of Takeda-ism Integrity, Fairness, Honesty, and Perseverance and are united by our mission to strive towards Better Health and a Brighter Future for people worldwide through leading innovation in medicine.

Here, everyone matters, and you will be a vital contributor to our inspiring, bold mission. At Takeda, you will make an impact on people s lives including your own.

BioLife is an industry leader in operating high-quality plasmapheresis centers throughout the United States. At BioLife Plasma Services, we excel at caring. Caring for the quality of our lifesaving services, caring for the donors who help make it happen, and caring for the communities we call home. Improving Lives. Improving life for everyone.

BioLife s employment opportunities are among the best, offering competitive pay, immediate benefits, paid time off, on the job training, advancement potential AND an environment full of fast-paced fun all while working to save lives.

This is a remote position, open for qualified candidates nationwide

Primary Role

Performs compliance audits and quality systems assessments thereby ensuring compliance with all applicable processes, systems and provisions of the Quality System (including regulatory requirements of the intended country of sale). Conducts assessments of operations facilities, service organizations, suppliers, and general offices using the Takeda quality manual, applicable division and / or local procedures, applicable country regulations, directives, standards, inspection guidelines and compendia as requirements.

Essential Functions


Prepares for the audit/assessment activity by researching background information, including previous audit results. Assists in planning and developing assessment strategy and logistics. (10%)
Performs the audit / assessment by collecting and analyzing objective evidence regarding issues and risks. Reports findings (verbally and written) to management. (45%)
Evaluates corrective and preventive action responses to the assessment findings for adequacy, including root cause and timeliness. Elevates issues to management, as appropriate. (10%)
Maintains the assessment file through the process to closure. (15%)
Reports extended corrective actions to management. (5%)
Performs follow-up audits to confirm corrective and preventive action is effective. (5%)
Remains current in regulatory trends through attendance at related conferences, seminars, meetings and other training methods such as independent study of periodicals, Internet or other literature. (5%)
May participate in the development and delivery of GXP training programs. (5%)

Education & Experience Requirements

Minimum Bachelor's degree in a scientific or technical discipline.
Minimum of three years of experience in manufacturing or quality operations in a pharmaceutical, device, or biotechnology environment

Previous quality auditing experience highly desirable
ASQ auditor accreditation is highly desirable.
Key Skills and Competencies
Living our leadership behaviors is a basic expectation for all Takeda employees. Takeda expects all employees to embody the following:

Leadership Behaviors
Be Positive
Be Accountable
Be Results Oriented
Be An Excellent Manager of Self and Others
Must have excellent verbal and written communication skills, sound judgment and analytical skills to enable assessment of risk.
Excellent interpersonal skills.
Resourceful, self-reliant, self-motivated and confident.
Able to work independently and be flexible to changing priorities.

Other Job Components

Complexity and Problem Solving
Incumbent regularly assesses quality system compliance.
Reports compliance level to management, and may identify and may recommend changes to processes to drive compliance.

Internal and External Contacts
Incumbent seeks advice from Regulatory, Quality, Operations, Supply Chain and other key stakeholders regarding quality and quality system requirements (Internal)
Job advises employees and managers regularly on a variety of topics, including quality systems, quality compliance, quality auditing processes, etc. (Internal)

Other Requirements
Able to read, write, speak and understand English.
Up to 60% domestic travel

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.

EEO is the Law -

EEO is the Law Supplement -

Pay Transparency Policy -

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.

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