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Shire Sr. Quality Assurance Specialist in Thousand Oaks, California
Responsible for the managing the day-to-day Quality operations for Formulation and Filling (FF) Manufacturing. Identify and assess quality risk in activities and processes according to guidelines and Shire standard operating procedures.
Proficient in facility Quality Systems particularly Change Control and Exception Management/CAPA.
Knowledgeable of FF Manufacturing Processes in order to support day to day activities including troubleshooting, problem solving, decision making, and resolution execution. Proactively participates in processes and serves as a driver for general process/system improvements.
Essential Duties & Responsibilities
Responsible for review of quality related documentation and approval of events and change control including assessing the risk and impact to the process and/or product as applicable.
Assess impact of new regulations on current practices, initiate document change proposals, prepare/review/approve protocols to justify process changes, approve validation protocols, and assist with training and auditing as appropriate.
Lead ongoing daily departmental activities for areas of direct responsibility and when required assist other Quality areas in the successful performance of these activities.
Responsible for overseeing the closure of nonconformance reports pertaining to areas of responsibility. Able to apply problem solving tools and methods to coordinate and/or lead investigation teams. Lead investigations (i.e. CAPA) for process failures within respective areas.
Serve as QA representative as a core team member for projects, participate and own project milestones and implementation actions.
Responsible for trending and analyzing data, and presentation of Quality System indicators to all organizational levels.
Services as a subject matter expert in internal, corporate and external audits for areas of expertise.
Must be recognized by all levels of the facility as an expert in their area and be able to demonstrate leadership ability.
Acts as a change-agent and drives continuous improvement activities within the QA organization and across the facility as assigned.
Assume a leadership role in absence of the Quality Manager.
May perform other duties as assigned.
May perform other duties as assigned.
Proficient in problem solving through the use of continuous improvement tools; certification desired in ASQ, Green Belt, Lean, or equivalent
Strong verbal, written and oral communication skills.
Able to present business indicators to senior management
Demonstrates proficiency in multiple quality systems including exception management, change control, document control, product release, supplier quality, etc. with strong decision-making skills utilizing risk management
Lead multiple tasks/projects within timelines
Demonstrates leadership by identifying improvement opportunities and implementing solutions
General knowledge of cGMP (US, EU, Canadian, Japan) required
General knowledge of manufacturing processes, laboratory operations and/or critical systems required
Able to present areas of responsibility to regulatory agencies during inspections
Able to assume responsibilities of Manager
Able to supervise employees, conduct performance reviews, establish development plans and manage resources.
Passion for Improving Lives. Must be able to put our patients at the center of everything we do.
Quest for Innovation. Must be able to operate with agility and a learning mindset so that we can accelerate breakthrough innovations.
Inspired Teams environment. Must be able to thrive in diverse high performing teams.
Engaged with the World Around Us. Must be able to embrace change and seek diverse perspectives and partnerships to benefit patients and make a positive impact on the world.
Education and/or Experience
Bachelor's degree in Sciences or Engineering and 5-8 years’ experience in quality operations within a biotechnology, biologics, or pharmaceutical manufacturing facility. Previous supervisory experience preferred.
Normal office environment.
May be required to travel for business reasons, e.g. training and meetings.
Will have interaction with other people.
Pace may be fast and job completion demands may be high.
Must be able to work in controlled clean room environment requiring special gowning. Requirements include: no jewelry or cosmetics. Special gowning requires complete coverage of head, face, hands, feet and body. Personal protective equipment must be worn due to safety requirements.
Gowning in controlled areas – Frequently - May require periodic standing in manufacturing areas.
Drive - Rarely - as to non-commercial motor vehicles.
Communication - Constant - Employees must be able to communicate orally and in writing in a clear, concise undersandable manner to supervisor and instruct co-employees. Including use of computer, telephone and related communication instruments
Definitions: Rarely: 1-5 percent of the time in a ten hour day Occasionally: 6-32 percent of the time in an ten hour day Frequently: 33-66 percent of the time in an ten hour day Constant: 67-100 percent of the time in an ten hour day
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
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.