Shire Quality Associate – Critical Systems/Facility Engineering in Los Angeles, California
This position will be part of the QA organization primarily responsible for the Critical Systems and Facilities, both Los Angeles and Van Nuys Facilities. Additional responsibilities for managing/supporting key projects for the QA department to drive improvements in safety, quality, compliance, customer satisfaction and continuous improvement in alignment with the Los Angeles Facility strategic plan. Works on problems of diverse scope where analysis of situation or data requires evaluation of identifiable factors. Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.
Essential Duties and Responsibilities
Supports Critical Systems and Facilities Engineering for both LA and Van Nuys in various QA capacities.
Supports top quality issues and improvement initiatives for both LA and Van Nuys.
Represent QA support for Critical Systems and Facilities Engineering during regulatory and customer audits.
Understands and deploy the quality systems that ensure products conform to defined requirements
Understands and ensures compliance to all applicable Shire policies and procedures as well as state, federal and international regulations.
Coordinate the efforts between the Quality Assurance and Critical Systems & Facilities, Manufacturing departments to ensure compliance and timely resolution of exceptions.
Interacts frequently with peers and senior management in ensuring the success of the business.
Identifies and manages continuous improvement projects with the objective of achieving quality, reliability and cost improvements.
Lead ongoing daily departmental activities for areas of direct responsibility and when required assist other Quality areas in the successful performance of these activities.
Participate in or manage quality assessments of internal operations and suppliers to analyze compliance and assess risk.
Lead in-plant audit ready status efforts for assigned areas and assist other areas within the facility in understanding FDA, ISO and Shire quality requirements.
Manages Interactions with regulators and customers concerning the quality of products, systems and processes.
Support the project initiatives within the LA facility.
Support the development and maintenance of the department budget
Cross-training to support departmental lQA initiatives as necessary
Thorough knowledge of the regulatory environment for manufacture of therapeutics/biologics.
Thorough knowledge of quality system processes.
Strong leadership skills and demonstrated success in managing a team.
Strong analytical and problem solving skills.
Good verbal and written communication skills.
Success working with multifunctional, global teams.
Good interpersonal, influencing, and negotiation skills required.
Good project management skills
Knowledge of Plasma Fractionation business
Education and/or experience
Bachelor’s degree in Science, Engineering or other related technical field; advanced degree in the life sciences, physical sciences or engineering preferred.
3+ years in Quality, Manufacturing, Engineering or related technical field in the biotech/pharma industry.
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.
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.
Some travel required
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.
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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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.