About the role:
Successfully perform all primaryQuality Assuranceactivitiesfor Teardown/ Fractionation(B5)orPurification(B8),which include providing dailyQualityon the Shop Flooroversight: manufacturingbatch record and documentation reviewfor accuracy and complianceto procedure,Quality on theShop Floorwalkthroughs to assurecGMPcomplianceand timely resolution of issues,participating introuble shooting and problem solvingofmanufacturingissuesas well assupportingday to day change control processes (insignificant changes and return to operations) in accordance withFDAand Regulatorystandards,ISO requirements andinternalstandard operatingprocedures.
Assure compliance withcGMP, GDDP and company proceduresand support internal and external audits. Identifypotential Quality andcompliancerisks in activities and processes according toproceduralrequirements, Takeda QualityStandardsandpractices.Provide assessments to supportcurrent regulatory requirements i.e., FDA, ISO, andTakedaQuality Systems, and serve as a plant resource for compliance to these requirements.UpholdTakeda’sQuality Culture elements ofkeeping it simple, taking pride in doing it right, ensuring a speak up culture and owning and demonstrating commitment to Quality.
How you will contribute:
- Partner upwith Manufacturing forQuality on the Shop Floorcollaborationto ensuresoundQuality decisionsaremadewithcompliance tostandards and procedures.
- Review and release batch records and associated documents against Standard Operating procedures and internal guidelines as assigned.
- Perform scheduled and unscheduled walkthroughs of Manufacturing,facilities and supporting areas for verification of acceptable cGMP Facilityand equipmentconditionsand resolution ofactions.
- Interpret and evaluateissues for acceptability to standards,proceduresand regulatory requirements.Obtain resolution onissuesidentified asnon–conformance.Provide guidance ondocumentationof issues with immediate corrections and corrective actions.
- Work closely with manufacturing teams in proactive functions that impact production, solve problems, improve quality, increase efficiency, generate cost savings, and provide new product support.
- Performinitial investigations and reviewsDeviations, CAPAs, and User Interventions, etc.
- Identify areas for improvements to mitigate recurring non-conformances and drive continuous improvement.
- Review and release batch records and associated documents against Standard Operating Procedure (SOPs) for accuracy and assure compliance to procedures based on regulatory requirements and internal guidelines.
- Work with change owners to ensure change packages are accurate and meet requirements set forth.
- Develop, lead and execute project(s)as assigned by management.
- Administer and maintain relevant databases, prepareand issuereports as defined by the area.
- Assist ininternalself-inspections and externalaudits by collecting and reviewing documents as assigned by management.
- Provide guidance andtrainingof employees within the departmentas assigned by management.
- Provide guidance to members of other departments with regards to critical step verification.
- Support activities forotherdepartmentsas assigned by management.
What you bring to Takeda:
- KnowledgeofRegulations, Application of GoodData andDocumentation Practices (GDDP) and application of current Good Manufacturing Practices (cGMP).
- Generalknowledge ofbiopharmaceutical/biotech manufacturing theories and processes.
- Goodinvestigational experience. Abilitytosee the actual processon the floor(GEMBA)whereissueoccurred andrecommendimmediate corrections androbustcorrectiveactionsfor determinedrootcause.
- Goodverbalandwritten communication skills.
- Strong interpersonaland partneringskills.
- Abilityto operate in a dynamic, cross-functional, fast pacedenvironment.
- Be able to be flexibleand accept new assignments.
- Resultdrivenwith ideas to drive continuous improvementandprocess simplificationwithbreakthrough solutions.
- Havegreatattention to detail.
- Be able to handle multipletasks and projects concurrently.
- Have strong organizational skills and the ability to plan, follow-up, and implement tasks.
- Have goodcritical thinking andproblem-solvingskills (DMAICandLean).
- Be able to perform and analyze trendingusingDeltaVsystemand/or EBM.
- Be able to generate spreadsheetsand preparereportsandPowerPoint presentations on the computer.
- Be able to support departmental/ plant goals.
- Be able toreviewand approveinvestigationsas assigned
- Be able to work independently and with intermittentsupervision.
- Yellow Belt/Green Belt training/certification preferred.
Required: Typically requires aBachelor'sdegree in science, engineering orotherrelated technical field strongly preferred. 2+ years of related experience.
- Must be able to lift, push, pull and carry up to 25 lbs.
- In general, the position requires a combination of sedentary work and walking around observing conditions in the facility.
- Must be able to work in controlled environments requiring special gowning. Will be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet and body.
- No make-up, jewelry, contact lenses, nail polish or artificial fingernails may be worn in the manufacturing environment.
- Will work in a cold, wet environment
- May be required to work in a confined area.
- Someclean roomand cool/hot storageconditions.
- Must be able to work multiple shifts, including weekends, as assigned.
- Must be able to work overtime as required.
What Takeda can offer you:
- Comprehensive Healthcare: Medical, Dental, and Vision
- Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan
- Health & Wellness programs including onsite flu shots and health screenings
- Generous time off for vacation and the option to purchase additional vacation days
- Community Outreach Programs and company match of charitable contributions
- Family Planning Support
- Professional training and development opportunities
- Tuition reimbursement
At Takeda, our patients rely on us to deliver quality products. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product. In this role, you may:
- Work in a controlled environment requiring special gowning and wear protective clothing over the head, face, hands, feet and body. This may include additional hearing protection for loud areas.
- Need to remove all make-up, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment.
- Work in a cold, wet environment.
- Work multiple shifts, including weekends, or be asked to work supplemental hours, as necessary.
- Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.
More about us:
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.
Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
This posting excludes Colorado applicants.
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.Locations
USA - CA - Los AngelesWorker Type