Shire Quality Analyst I (2nd shift) in Lawrence Manufacturing Facility, California

Summary:

Responsible for performing the day-to-day quality operations for the Quality Assurance (QA) department within the Quality organization, including batch record review on the floor and quality inspection activities associated with Packaging and BAXJECT III processes. Perform the final review of QA Inspection documentation to support Filled Unlabeled Vial (FUV) and Final Drug Product (FDP) release. Identify and assess quality risks in activities and processes according to regulatory agency requirements and guidelines and Shire quality practices. Initiate and complete event investigations to identify why a deviation occurred and to minimize/eliminate reoccurrence. Revise documents to drive continuous improvement including streamlining processes and maintaining GMP compliance. Support departmental projects and any quality working teams when required.

Essential Duties and Responsibilities

  • Responsible for QA Inspection activities associated with visual inspection, assembly, packaging, and label stores management for BaxJect III manufacturing.

  • Perform on the floor lot/batch documentation review to ensure compliance with all requirements.

  • Initiate and perform nonconformance investigations, which may include assigning root cause, ascertaining material/product impact, and determining appropriate corrective action(s).

  • Revise documents to support process improvements, corrective actions, corporate/division compliance, and audit commitments.

  • Assist in external and internal audits by maintaining audit records, collecting and creating relevant data reports from databases, and presenting processes during tours.

  • Manage activities of self in achieving defined Quality goals in an efficient, accurate and timely

  • Support in-plant audit ready status efforts for assigned areas and assist other areas within the facility in understanding FDA, ISO and Shire quality requirements.

  • Support and drive continuous improvements consistent with the divisional strategy and ensure compliance to all applicable state, federal and international regulations.

  • Administer and maintain relevant databases, preparing and issuing reports as defined by the area as well as developing custom reports as needed.

  • Must demonstrate strong leadership, influence, and cross-functional collaboration skills and able to work efficiently in a cross-functional team environment.

  • Represent department in cross-function projects

  • Skilled in use of electronic word processing, spreadsheet, project management, and presentation tools such as Microsoft Office (Word, Excel, Project, PowerPoint).

  • Ability to prioritize and thrive in a fast-paced environment.

  • May perform other duties as assigned.

Qualifications

  • Have strong interpersonal skills

  • Have the ability to operate in a dynamic, cross-functional environment.

  • Be able to be flexible.

  • Result Driven- manufacturing process simplification and also yield improvement ideas, generate breakthrough solutions.

  • Be able to have great attention to detail is necessary.

  • Be able to handle multiple tasks and projects concurrently

  • Have strong organizational skills and the ability to plan, follow-up, and implement tasks.

  • Have good critical thinking and problem solving skills (DMAIC, Six Sigma, and Lean).

  • GEMBA - good investigational experience who goes to the floor see the actual process where event occurred and who also implement robust Corrective Actions for the correct Root Causes.

  • Yellow Belt/Green Belt training/certification preferred.

  • Have good verbal and written communication skills.

  • Have general knowledge of biotech manufacturing theories and processes.

  • Have knowledge of FDA and EMA Regulations, Application of Good Documentation Practices (GDP), and application of current Good Manufacturing Practices (cGMP).

  • Be able to perform and analyze trending through the use of DeltaV system.

  • Be able to generate spreadsheets and power point presentations on the computer.

  • Be able to support departmental / plant goals.

  • Be able to review and approve investigations

  • Be able to work independently and with intermittent supervision

Education and/or experience

  • Bachelor's degree in science, engineering or other related technical field strongly preferred. 2+ years of related experience.

Physical Demands

  • Physical Demand Level - MEDIUM.

  • Rarely Lifting - Up to 50 pounds.

  • Frequent Lifting 15 - 35 pounds.

  • Standing - Frequent - Function performed as employee supervises and assists in manufacturing areas. Total standing and walking can be up to 7 hours in and 8 - hour workday.

  • Walking - Frequent.

  • Sitting - Frequent - Production of reports.

  • Pushing/Pulling – Frequent - Required in some positions to inspect equipment, access alternative areas of facility, move labeling carts.

  • Overhead reaching - Occasional- to obtain and place materials for inspection or reach needed materials.

  • Squatting - Occasional - To observe materials and equipment at floor level. Crawling - Rarely.

  • Hand/Finger Feel - Frequent - Employees are required to handle the individual packages and handle small fine parts. Parts will have multitudes of textures and sizing.

  • Gripping/Grasping - Frequent - Employees are required to use hand tools and possible other equipment to assist in the manufacturing and quality assurance of products.

  • Drive - Rarely - as to non-commercial motor vehicles.

  • Communication - Constant - Employees must be able to communicate orally and in writing in a clear, concise understandable manner to supervisor and instruct co-employees and staff. Including use of computer, telephone and related communication instruments.

Working Environment

  • Must be able to work more than 8 hours a day or 40 hours a workweek as required.

  • Overtime may be required at times and include weekends and holidays.

  • 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.

  • Possible exposure to cold storage conditions.

  • May be around moving equipment and machinery (e.g. forklifts, pallet jack).

  • May be required to work or be assigned to a different shift as needed.

  • Will have interaction with other people.

  • Pace may be fast and job completion demands may be high.

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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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.