Posted to MedZilla on 2/23/2019

Takeda Pharmaceuticals

US-CA, Quality Specialist SR0030173-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.

Plasma Release - (80%):
Review documentation associated with plasma dispositioning and perform quality review and release for plasma to be used in Teardown in the Automated Plasma Dispositioning System (APDS).
Review shipment documentation associated with plasma shipments received and perform quality review in the Automated Plasma Dispositioning System (APDS).
Ensure destruction of unsuitable plasma units, as necessary and ensure proper documentation: perform required system transactions.
Communicate with quality, manufacturing, technical support groups, and plasma supplier staff to ensure availability of plasma and to resolve plasma related discrepancies.
Support and participate in any quality related tasks pertaining to plasma (e.g. visual inspection and inventory of units, physical release of plasma to Teardown, training/execution of protocols) will be performed in cold environment (-27 C to +8 C).
Place shipments and plasma centers on hold and remove holds based on sufficient support documentation and approvals.
Provide and present to management monthly statistical data for key metrics, such as plasma receipts, plasma on hold and other key information. Create and present PowerPoint slides for the purposes of presenting data, as required.
Identify and inform PQR Management of plasma related discrepancies.
Interface with Quality, Manufacturing, Technical Support Groups, and Donor Center staff to resolve plasma related discrepancies.
Lead PQR inventory cycle counts; maintain documentation and report to the Inventory Specialist the results.
Create report presentations as requested.
Seek and communicate system improvements and process improvements; support implementation.
Identify and lead continuous improvement initiatives.

Quality System 15%:
Initiate events in Trackwise 8 for internal discrepancies associated with Plasma Quality Release and Plasma Operations processes and for plasma supplier discrepancies; conduct investigations and identify corrective/preventative actions.
Review and ensure discrepancies are documented, investigated, and resolved using the appropriate PQR Quality System according to set deadlines.
Revise department owned procedures for compliance with Corporate, BioLife, and Regulatory requirements and implementation of continuous improvement initiatives as required.
Utilize excellent grammar, mechanics and proofreading skills to generate clear, concise, and accurate documentation (e.g. NCE, SCR, QER, formal memorandums, electronic mail, etc.)
Conduct process audits to ensure activities and documentation conform to standard operating procedures and regulatory requirements.
Conduct process audits to ensure activities and documentation conform to standard operating procedures and regulatory requirements.
File documentation according to procedural requirements and ensure retention policies are met.

Special Projects 5 %:
Identify, lead and implement continuous improvement projects.
Actively participate in internal or external audits as required (e.g. runner, communication flow, document reviewer, etc.) and support the closure of audit observations within the specified timeframe.
Lead and execute small projects/continuous improvement initiatives. Participate in Kaizens, Process Mapping Sessions, Quality Working Teams (QWTs), Problem Solving Teams, etc.
Support special projects / protocols execution.

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.

Please visit our website at


* If a direct employer requests that you go to their web site and complete your application there in order to be
  considered, please do so. Applications for all positions are subject to each employer's specific requirements.