Shire Quality Analyst II (Pharma Operations) 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.

Successfully perform all primary activities which include providing daily quality assurance to operations, review and release of electronic batch records and associated documents within the manufacturing facility, provide support on change control processes, and 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 Shire Quality practices.

Review and release electronic 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 day to day change control processes (insignificant changes and return to operations) in accordance with internal procedures and ensure compliance with the FDA and ISO requirements.

Good understanding and knowledge of current regulatory requirements i.e., EBM, Delta V, JD Edwards, LIMS, FDA, ISO, and Shire Quality Systems, and serve as a plant resource for compliance to these requirements.

Essential Duties and Responsibilities:

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

  • Provide oversight to ensure a GMP area is maintained for the Building 8 area on shift.

  • Obtain resolution on areas identified as non–conformance.Assess and evaluate results in terms of acceptability to standards, procedures and regulatory requirements.

  • Perform initial investigations and reviews Events, CAPAs, and product impact assessments on User Interventions.

  • Process the closure of Non-Lot Related Events.

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

  • Review electronic batch records and associated documents against Standard Operating Procedure (SOPs) for accuracy and assure compliance to procedures based on regulatory requirements and internal guidelines, etc.

  • Assist in the management, technical review, and closure of Product Holds (PH).

  • 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, preparing and issuing reports as defined by the area as well as developing custom reports as needed.

  • Assist in 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 critical step verification.

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

Qualifications:

  • Have strong interpersonal skills

  • Have the ability to operate in a dynamic, cross-functional environment.

  • Be able to have great attention to detail is necessary.

  • Be able to handle multiple tasks and projects concurrently

  • Have strong organizational skills and the ability to plan, follow-up, and implement tasks.

  • Have good critical thinking and problem solving skills.

  • Yellow Belt/Green Belt training/certification preferred.

  • Have good verbal and written communication skills.

  • 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).

  • Be able to perform and analyze trending data.

  • Be able to generate spreadsheets and power point presentations on the computer.

  • Be able to support departmental / plant goals.

  • Be able to review and approve investigations

  • Be able to work independently and with intermittent supervision.

Education and/or experience:

Bachelor’s degree in Life Sciences, Engineering, or other technical field and 3-5 years of relevant experience in Quality with a pharmaceutical company or other similarly regulated industry.

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.

  • Must be able to work overtime as required (APPLICABLE TO SNE only).

  • 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.