Sr. Manufacturing Compliance Investigator

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Job Description

About the role:Perform root cause analysis for various deviations in Manufacturing and QC Labs, including OOL, OOS. Responsible for timely documentation of comprehensive Investigations related to environmental monitoring, personnel monitoring, critical systems monitoring, in-process product monitoring, final container testing, and stability testing. Work closely with the corresponding manufacturing, quality assurance, or critical systems personnel to investigate suspect results. Will lead Investigation teams and drive root cause identification with team setting. May be involved with leading teams, encouraging teamwork, problem-solving and making sound (e.g. technical, compliance, and operations) assigned decisions. Analyze bioburden data and prepare presentations for management. Participate and/or drive completion of improvement projects.How you will contribute:

• Conduct thorough scientific, defensible Investigations for any OOL, CAPA, or OOS excursion.
• Conduct and document Investigation In a timely manner to support the on-time closure of on conformances to meet product fulfillment dates.
• Conduct Investigative sampling pf the manufacturing areas as appropriate. This requires qualification on general sampling techniques (e.g. swab sampling) and basic testing methodologies.
• Support problem solving sessions through application of the problem solving tools and methods to coordinate and/or lead investigation teams. Will lead routine Investigations and may be required to lead complex investigations.
• Actively contribute to a team setting at the Los Angeles Manufacturing Facility and potentially with other work teams increase efficiency, solve problems, generate cost savings, improve quality, and provide new product support, as needed.
• Work closely with other QA departments and manufacturing operations to conduct investigations, determine appropriate corrective actions, and drive closure of deviations in accordance with cGMP and quality systems.
• Maintain access to key quality system databases and ensure accuracy of those databases as they pertain to OOL/CAPA/OOS Investigations.
• Maintain training on general laboratory procedures to enable adequate review of test data, including overall GDP.
• Assist In developing Investigative sampling plans and/or experiments for root cause analysis of laboratory test techniques or rapid Identification of microbial contamination sources.
• Lead and/or actively contribute to a team setting with other work teams to increase efficiency, solve problems, generate cost savings, improve quality and provide new product support.
• Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, GLP, QSR and cGMP regulations. Investigate deviations and write exception documents, when assigned.
• Ensure personal training requirements are met and that training records are current.
• Lead or support Deviation Free Initiatives
• Prepare root cause and/or trend analysis to management during routine operation mechanisms (e.g. Management Review and CAPA Review Board).
• Must be willing to work flexible hours if necessary
• Must be able to work independently with minimal supervision.
• Active Yellow Belt Certification.
• Ability to handle multiple tasks concurrently and complete tasks in a timely manner.
• Effective organizational skills and ability to plan and suggest resolutions to technical or resource problems.
• Good organizational skills and ability to plan and suggest resolutions to technical problems.
• Proficient with lab application software and able to learn new computer systems and programs in a timely manner.
• Capable of applying sound decision-making to problem-solve technical, compliance, or operational problems as assigned.
• Computer literate and competent with a general knowledge of word processing and spreadsheets (such as Microsoft Office).
• Must be detail oriented, conscientious and have a high reading comprehension skill.
• Good understanding or critical manufacturing and facility processes.
• Effective interpersonal communication and influencing skills. Must have effective verbal and written communication skills. Effective presentation skills a plus.
• Understand scientific strategies and be able to invent new processes or new avenues of investigation.
• Must be able to understand and apply cGMP/GOP, follow CTP/SOPs, and meet EHS requirements.
• Must be able to learn new computer systems and programs in a timely manner.
• Demonstrate good process, critical system understanding and lead investigations to provide comprehensive investigation write up.
• Capable of navigating through Quality systems and has working knowledge of event management system.

What you bring to Takeda:

• High School Diploma or GED plus 5+ years of related experience OR Bachelor’s degree in science, engineering or Other related technical filed and 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
• Must be able to work multiple shifts, including weekends.
• May be required to work or be assigned to a different shift as needed.
• 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.

Base Salary Range: $63,700.00 to $91,000.00. Employees may also be eligible for Short Term and Long-Term Incentive benefits. Employees are eligible to participate in Medical, Dental, Vision, Life Insurance, 401(k), Charitable Contribution Match, Holidays, Personal Days & Vacation, Tuition Reimbursement Program and Paid Volunteer Time Off.

The final salary offered for this position may take into account a number of factors including, but not limited to, location, skills, education, and experience.

#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