Shire Compliance Investigator II in Los Angeles, California

Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmic, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.

Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.

The Compliance Investigator II will initiate events as needed, conduct root cause investigations, and close events for Manufacturing under the direction from Compliance Management. Support in assigning proper corrective actions and facilitate implementation. Additional responsibilities will include support of department’s compliance and continuous improvement programs.

Essential Duties and Responsibilities

  • Write and manage events (CAPA investigations, UIs, ICARs, OOXs, containment and/or corrective actions) under the direction of Compliance Management.

  • Lead and/or facilitate Kaizens and problem solving events. Lead the investigation closure of manufacturing compliance related documents. Using quality and statistical tools to identify and implement proper corrective and preventative actions to manufacturing non-compliance.

  • Represent the departments during the product release process, compliance and Continuous Improvement projects and audits.

  • Participate in exception related meetings and provide feedback, leadership and support to manufacturing supervisors, trainers and manufacturing technicians on the status of compliance of the department.

  • Conduct mediations to ensure timely release of product for customers. Assist in meeting product release time goals.

  • Emphasize training programs designed to enable staff to consistently execute all manufacturing processes with strict compliance to cGMPs and EHS regulations.

  • Identify and implement process improvement and Value Improvement Projects (VIP) to drive success in the areas of compliance, throughput, workplace safety, cost effectiveness, and product lead time.

  • Participate in regulatory and non-regulatory audits.

  • Other duties as assigned.

Qualifications

  • Demonstrate interpersonal skills with the ability to interface and influence with personnel of all levels and participate effectively and efficiently in a team environment.

  • In-depth process knowledge of related manufacturing equipment and processes.

  • Ability to analyze and interpret scientific and statistical data.

  • Strong professional writing and verbal skills.

  • Experienced understanding of cGMPs and other regulatory guidelines applicable to the medical/bio-tech industry.

  • Good problem solving and analytical skills.

  • Lead investigation and provide comprehensive investigation write up and/or presentations

  • Working knowledge of Quality Systems

  • Good computer skills and working experience with Microsoft Office applications.

Education and/or experience

BS/BA in engineering or scientific discipline, or in a related field with 2+ years minimum experience. Technical writing experience preferred. MS degree with 1+ years of relative experience or PhD with 0 years of experience.

Physical Demands

  • 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.

Working Environment

  • 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.

Equal Employment Opportunity

Shire is an Equal Opportunity Employer committed to a diverse workforce. Shire 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 - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf

EEO is the Law – Supplement - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCPEEOSupplementFinalJRFQA508c.pdf

Pay Transparency Policy - https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf

Reasonable Accommodations

Shire 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.

Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.

Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.