Sr. Quality Analyst - QA Operations at Baxalta U.S., Inc. in Los Angeles, California

Job Description:

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Job Description

Shift 3 (Nights): This position reports to Night (3) shift. This shift schedule is Monday-Friday from 10 PM to 6 AM. Due to business need, on select occasion employees may be required to work overtime and/or support operations on an alternate shift.

About the role:

Daily quality assurance to operations,

Participate and support internal and external audits

Assure compliance with GMP, GDP, GLP, and company procedures

Identify and assess regulatory and quality risks in activities and processes according to regulatory agency rules and guidelines, and Takeda Quality practices

Review and release batch records and associated documents against procedures for accuracy and assure compliance to procedures based on regulatory requirements and internal guidelines, etc.

Provide assessments to support daily change control processes (insignificant changes and return to operations) observing internal procedures and ensure compliance with the FDA and ISO requirements

What you bring to Takeda:

• Partner with shift manufacturing to ensure sound quality decisions are made.


• Provide oversight to guarantee a GMP area is maintained for the Building 5 area on shift.


• Obtain resolution on areas identified as non-conformance.


• Interpret and evaluate results concerning acceptability to standards, procedures, and regulatory requirements.


• Perform initial investigations and reviews of Deviations, CAPAs, and User Interventions.


• Identify areas for improvements to reduce recurring non-conformances and drive continuous improvement.


• Review and release batch records and associated documents against Standard Operating Procedures (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 and execute projects as assigned by management.


• Administer and maintain relevant databases, preparing and issuing reports as defined by the area as well as developing custom reports.


• Support external and internal audits by collecting and reviewing documents as assigned by management.


• Provide guidance and training of employees within the department.


• Provide guidance to members of other departments with regards to important step verification.


• Support activities for another section or department as assigned by management


• Must be proficient in written and oral English.


• Have general knowledge of biotech manufacturing theories and processes


• Have knowledge of FDA and EMA Regulations, Application of Good Documentation Practices (GDP), and application of current Good Manufacturing Practices (cGMP)


• Can trend and analyze data using DeltaV system and/or EBM


• Proficiency with Microsoft apps


• Typically requires bachelor's degree in Science-Chemistry or Biological Science. 4+ years of experience.


• Desired: Yellow Belt or Green Belt Certification


• Must be able to lift, push, pull and carry up to 25 lbs.


• In general, your work will be a combination of sedentary work and walking around observing conditions in the facility


• Will work in controlled environments requiring special gowning - will 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 and/or wet environment


• Must be able to work multiple shifts, including weekends


• Non-Exempt Roles only: Must be able to work overtime as required


• May be required to work in a confined area


• Some clean room and cool/hot storage conditions

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

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.

Empowering our people to shine:

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.

Location and Salary Information: This post excludes CO applicants

#GMSGQ #ZR1

EEO Statement

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 Angeles

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time