Shire Sr. Quality Analyst - QA Release in Los Angeles, California

This position is responsible for Quality Assurance activities and performs ongoing daily departmental activities tied to Fulfillment. Must be able to handle and manage multiple projects. Demonstrate effectiveness in task completion, decision-making, exception management, training, problem solving and team leadership. Support or Assist PMT, QWT, Kaizen or equivalent focus type group activities as needed. A functional understanding of EBM, EBR, Delta V, FDA, ISO and Quality systems is also required.

Essential Duties and Responsibilities

  • Responsible for reviewing and approving pertinent documents, records and reports such a Manufacturing Batch Records (MBRs), Forms, etc. against Standard Operating Procedures (SOPs) related to Bulk Manufacturing (B8 and B5) for accuracy and compliance to procedures based on regulatory requirements and internal guidelines, etc. which comprises the majority of the work performed.

  • Perform ongoing daily departmental activities related to Product Releases and resolve any issues tied to Product Release as assigned. Perform the review, approval, and authentication of Product Release Documentation as assigned.

  • Responsible for initiating, tracking, investigating and completing documentation associated with exceptions and corrective actions resulting from process, equipment and facility deviations for the areas as needed.

  • Serve as a team member and/or assist in CAPA Investigations for significant issues.

  • Responsible for technical review of Non –Conformance investigations including Events and Out Of Limits (OOLs).

  • Responsible for Final Review of Non-Lot Related Events, as needed.

  • Performs initial investigative actions on some Events, applying well-established techniques and procedures.

  • Assist in the management, technical review, and closure of Product Holds (PH) Associated with protocols related to the analyst’s area of responsibility.

  • Process the closure of Non-Lot Related Events, extension requests and commitment records in the Trackwise database.

  • Manage activities of self in achieving defined Quality goals in an efficient, accurate and timely manner.

  • Support multiple process/product improvement projects which may include any of the following - PMT, QWT, Kaizen, or other focus groups, design of experiments, validations, development of new methodologies and improving existing methodologies, data generation, report development and presentation.

  • Support in-plant audit ready status efforts for assigned areas and assist other areas within the facility in understanding FDA, ISO and Shire quality requirements.

  • Support in the development of customer awareness and understanding activities for areas of direct responsibility and, where appropriate, assist and support such activities throughout the facility.

  • Support with Internal and External Quality audits/assessments and provide ongoing feedback related to quality issues.

  • Support and drive continuous improvements consistent with the divisional strategy and ensure compliance to all applicable state, federal and international regulations.

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

  • Must demonstrate strong leadership, influence, and cross-functional collaboration skills and able to work efficiently in a cross-functional team environment.

  • Skilled in use of electronic word processing, spreadsheet, project management, and presentation tools such as Microsoft Office (Word, Excel, Project, PowerPoint).

  • Ability to prioritize and thrive in a fast-paced environment.

  • Must be willing to work flex hours and rotations, if necessary.

Qualifications

  • Strong interpersonal skills and great attention to detail are necessary.

  • Must be a strong team player with good problem solving, and good verbal and written communication skills.

  • Must be able to handle multiple projects concurrently, have computer experience and have knowledge of FDA Regulations, Application of Good Laboratory Practices, and Application of Good Manufacturing Practices.

Education and/or experience

Typically requires bachelor's degree - science, engineering or other related technical field preferred. 2+ years of related experience.

Physical Demands

  • Must be able to lift, push, pull and carry up to 10 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.

  • May be required to work in a confined area.

  • Some Clean Room and cool/hot storage conditions.

Notice to Employment / Recruitment Agents:

Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire’s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.

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.