Shire Sr. Quality Associate in Thousand Oaks, California
Responsible for managing the day-to-day operations for the QA Lawrence organization (QA Receiving & Inspection and Baxject III/Packaging operations). QA Receiving & Inspection operation includes raw material inspection, sampling, and release activities. Baxject III & Packaging operations include and not limited to support on CAPAs, Change Control, projects. Requires strong knowledge & experience in automated device assembly processes and sterilization of medical devices, including Vaporized Hydrogen Peroxide (VHP) sterilization methods. Identify and assess quality, product, and/or systems risk in processes according to established guidelines and Baxter standard operating procedures. Proficient in facility Quality Systems particularly Change Control and Exception Management/CAPA. Responsible for developing and supervising a staff of QA personnel and ensure compliance to appropriate regulations, Corporate/Division, and applicable facility procedures. Knowledgeable of Receiving & Inspection and Baxject III/Packaging 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
Supervision of Baxject III QA inspection team
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 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 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.
Assume a leadership role in absence of the Quality Manager.
May perform other duties as assigned.
Experience in medical devices, or Vaporized Hydrogen Peroxide (VHP) sterilization methods.
Knowledge of manufacturing processes, laboratory operations, and/or critical systems required.
Working knowledge of statistical tools associated with receiving/inspection processes.
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
Good interpersonal/communication/influencing/negotiation skills.
Good project management skills.
Working knowledge of FDA Regulations(211, 820), Application of Good Laboratory Practices, and Application of Good Manufacturing Practices.
Able to present areas of responsibility to regulatory agencies during inspections.
Living our leadership behaviors is a basic expectation for all Shire employees. Shire expects all employees to embody the following: Leadership Behaviors
Be Results Oriented
Be An Excellent Manager of Self and Others
Education and/or Experience
Bachelor's degree preferred in Science or Engineering. Minimum of 5-8 years of experience in quality operations or related field within a biotechnology, biologics, medical device or pharmaceutical manufacturing facility. CQM or CQE certification preferred.
Normal office environment and raw material warehouse 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.
May be required to work in a clean room environment wearing special garments. Additionally, personal protective equipment must be worn due to safety requirements.
Sedentary work. Sedentary work involves lifting no more than 10 pounds at a time and occasionally lifting or carrying articles like files, ledgers, and small tools. Although a sedentary job is defined as one, which involves sitting, a certain amount of walking and standing is often necessary in carrying out job duties. Jobs are sedentary if walking and standing are required occasionally and other sedentary criteria are met.
May be required to grip and grasp occasionally when moving and sampling materials.
May be required to stand and walk frequently to access other areas in the facility.
May be required to gown in controlled areas. May require periodic standing in manufacturing areas.
May be required to climb stairs rarely. Elevator access provided to 2nd floor area.
May be required to carry occasionally when filing or taking documents or supplies to other areas of the facility.
May be required to move head /neck frequently when communicating with co-workers/customers, answering the phone, and filing.
May be required to use repetitive motion frequently of hand, fingers, and wrist for the purpose of typing & data entry.
May be required to grip and grasp frequently when using computer mouse.
May be required to drive occasionally to the Westlake Village or Los Angeles facility for training/meetings.
May be required to use hearing frequently when communicating with personnel in person or on the phone.
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.
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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.