Shire Quality Associate III in Los Angeles, California

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, Ophthalmic, 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.

This position reports to Day Shift (Shift 1). Monday to Friday 6:00 am to 2:30 pm.

Essentially function as a primary operations delegate to the Biochemistry Laboratory Manager. Successfully perform all the primary activities as defined in the Biochemistry Laboratory Supervisor job position. Expert in liquid and gas chromatography and strong experiences in method development and validation. In addition, responsible for the overall logistics of the Biochemistry lab across all shifts (e.g. oversight of scheduling, driving completion of lab commitments, develop/monitor/analyze operational metrics, lead audit, etc.). Handle multiple department projects while demonstrating effectiveness in task completion, decision-making, empowerment of others, exception management, training, problem solving, and team leadership. Lead CAPA, QWT, Kaizen, or equivalent focus type group activities as required. A functional understanding of FDA, ISO and Shire Quality systems is also required.

  • Lead ongoing daily department activities across all shifts for the Biochemistry Laboratory including supervision of assigned personnel and when required assist other Quality areas in the successful performance of these activities.

  • Manage the overall logistics of the Biochemistry Lab across all shifts, including scheduling (e.g. final containers for LA/RLDD Release, Stability, special projects), Use Lean tools and make recommendations to improve operational efficiency and throughput.

  • Provide timely reporting of performance metrics. Develop, establish and monitor systems that focus on key indicators of laboratory control. Present department metrics to management through routine operating mechanisms

  • Be directly involved in and, where appropriate, lead multiple process/product improvement projects. These projects may be executed through CAPA, QWT, Kaizen, or other focus groups, design of experiments, studies, data generation and analysis, report preparation, presentations, and/or change control.

  • Primary audit escort for the Biochemistry Laboratory. Lead laboratory audit ready status efforts in understanding FDA, Shire, and other regulatory and quality requirements. Maintain a high level of expertise in current regulatory requirements and serve as a laboratory resource for compliance to these requirements.

  • Lead in the development of customer awareness and support activities for Biochemistry, and assist and drive such activities throughout the shifts.

  • Operational liaison with various customers (e.g. Manufacturing BUs, RLDD, Hayward, etc).

  • Make appropriate staffing recommendations through effective interviews, performance appraisals, and by driving appropriate accountability and feedback. Ensure employees have development plans.

  • Will be required to perform the operational responsibilities of the Biochemistry Laboratory Manager in his/her absence.

  • Prepare, review and revise, as required, CTPs and SOPs. Write memos, reports, protocols, CPAs and other appropriate documentation as they pertain to Biochemistry operations and procedures.

  • Drive Major Changes, as required, through Plant or Divisional Quality Systems

  • Lead Plant-wide initiatives as assigned.

  • Drive Lean principles such as 5S throughout daily work activities.

  • May perform removal of hazardous waste.

Qualifications

  • Ability to manage multiple tasks and projects concurrently and drive projects to completion in a timely manner.

  • Strong organizational skills and ability to plan and suggest resolutions to technical or resource problems.

  • Strong understanding of critical laboratory, manufacturing and facility processes

  • Understand scientific strategies and be able to recommend different technical strategies and analyses during investigations.

  • Computer literate and competent with an effective knowledge of word processing and spreadsheets (such as Microsoft Office). Capable of performing advanced data analysis through various applications software.

  • Strong interpersonal communication and influencing/negotiation skills. Must have strong verbal and written communication skills.

  • Represent the laboratory through technical presentations, material review board, management reviews, and other department presentations.

  • Capable of applying decisions-making to problem-solve technical, compliance, or operational problems as assigned.

  • Demonstrates strong abilities in leadership, guiding and coaching people and encouraging teamwork for supervisor-level employees and below.

  • Must be able to understand and apply cGMP/GDP, follow CTP/SOPs, and meet EHS requirements.

  • General knowledge of statistical techniques. Working knowledge of QSR, CFR, and USP.

  • Demonstrates basic project management skills.

  • Proficient with wide variety lab application software.

  • Expert in applying QLP or Shire Technical problem-solving tools; Lean Instructor or CAPA Investigator Certified a plus.

Education and/or experience

  • Bachelor's degree in Chemistry, or biological science with Analytical Chemistry or Laboratory coursework with 5+ years of relevant experience, including 3+ years of Quality experience

-or-

  • Master's Degree in Chemistry, or biological science with Analytical Chemistry or Laboratory coursework with 3+ years of investigational experience

Physical Demands

  • Must be able to lift, push, pull and carry up to 25 lbs.

  • 20/20 near vision required (corrected as acceptable).

  • Must be able to recognize and distinguish among the colors red, yellow, and blue.

  • In general, the position requires a combination of sedentary work, standing 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. This may include additional hearing protection for loud areas.

  • 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.

  • May be required to work or be assigned to a different shift to meet business needs. Must be willing to work off shift hours.

  • May be required to work in a confined area.

  • Some Clean Room and cool/hot storage conditions.

  • Will work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.

  • Must be able to work supplemental hours as necessary to complete work commitments.

  • Inside working conditions.

  • 5% travel as applicable.

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.