Shire Operations Analyst - Deviation Investigator in Thousand Oaks, California
This position will provide administrative support for the investigation, documentation and tracking of Quality deviations (non-conformance) and any regulatory audit responses involving the execution of the Quality deviation management system.
Essential Duties & Responsibilities
Good communication and problem-solving skills are essential.
Provide administrative support for the deviation management system.
Responsible for generating and managing electronic documentation of Quality deviations that occur in Manufacturing Operations.
Be a contributing team member in Quality deviation investigations.
Participate and facilitate continuous improvement and problem-solving activities (Kaizen, DMAIC) to prevent Quality deviations.
Provide status updates for deviations through presentations to upper management.
Work closely and provide guidance when need, to external and internal resources that directly impact manufacturing operations.
Responsible for presenting deviations to internal and external inspectors during regulatory inspections.
Collaborate with cross functional teams to help resolve complex problems, determine root causes, and help identify appropriate corrective and preventative actions.
Interface with Quality organization partners to achieve quality & compliance objectives and goals.
Responds to customer and/or management questions and problems related to projects/programs/policies, etc.
May perform other duties as assigned.
Intermediate problem solving and analytical skills are required using continuous improvement tools.
Six Sigma certification in Blue Belt or similar.
Excellent organization and time management skills.
Excellent written, verbal communication and computer skills required.
Knowledge of cGMP biotechnology manufacturing.
Advanced word processing skills.
Advanced spreadsheet skills.
Self-motivated individual able to work within a team environment.
Education and/or Experience
Bachelor’s degree preferred with 2-4 years of manufacturing experience.
Position requires frequent usage of a personal computer.
On occasion, the incumbent will be required to enter the production area and may therefore be exposed to hot, cold, and/or wet environments.
NOTE: Although assignments will be made specific to working hours, incumbent is expected to be flexible in this regard, with the understanding that process validation and production objectives may necessitate changes in work hours, duties and responsibilities.
May need to work in controlled or clean room 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 this work.
May be required to work or be assigned to a different shift as needed.
Must be able to work more than 8 hours a day or 40 hours a workweek as required.
Overtime may be required at times.
Will have interaction with other people.
Pace may be fast and job completion demands may be high.
The overall physical exertion of this position is sedentary work. Must be able to perform gowning operations, including donning over garment and head cover.
May be required to balance occasionally, when gowning for clean rooms.
May be required to stand occasionally, when inside clean rooms.
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, gender identity, 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.
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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.