Shire Sr. Quality Control Analyst - Microbiology in Los Angeles, California

This position reports to Weekend Swing (D) shift. This shift schedule is Saturday and Sunday 6:00 AM to 6:30 PM, plus a third day during the week which will be assigned by your supervisor . This shift requires working on all company designated holidays. Due to business need, you may be required to work your designated third day, in addition to the company designated holiday(s).

Participate in the development and technical writing of documentation for the validation of equipment and storage areas required to support testing of the Los Angeles Manufacturing Facility, as assigned. Perform environmental monitoring of clean rooms and controlled areas to support qualifications and routine sampling of the facility and critical utilities including WFI, compressed gas, nitrogen, etc. Conduct microbial based assays including bioburden testing, microbial quantification, and organism identification. Lead and/or drive completion of Lean or Six Sigma improvement projects and responsible milestones, as assigned. Must be effective in leading people, encouraging teamwork, problem solving, and making sound (e.g. technical, compliance and operations) assigned decisions. May function as a backup Supervisor, as assigned. Responsible of ensuring the daily operations of assigned functional area are met through scheduling, troubleshooting and coaching, as assigned.

Essential Duties and Responsibilities

  • Support and/or lead continuous improvement projects in the QM Laboratories such as 5S, Kaizen, Just-do-it’s, VIPs and Lean concepts and philosophy.

  • Lead daily operations to ensure coordination, as assigned.

  • Participate in the generation of test plans, protocols, and reporting documentation for the validation of equipment and storage areas required to support testing of the LA Facility including non-viable air samplers, viable air samplers, incubators, etc.

  • Perform microbial and particulate monitoring of clean rooms throughout the Los Angeles Manufacturing Facility. Work under some Supervision. May be responsible for overseeing daily work flow of assigned area.

  • Testing to support microbial identifications, bioburden analysis, biological indicators, growth promotion, and water groups. Will be required to read microbial plates and interpret test results. Some troubleshooting will be required.

  • Perform review of test data with application of GDP.

  • Use Global LIMS or other computerized systems for entering and approving test results.

  • Will be required to perform change requests (e.g. PR, RTO, Document Changes) when required and complete them in a timely manner.

  • Identification and issuance of Alert/OOL forms for out of limit results. May be required to conduct investigations and/or audits into Alert/OOL excursions.

  • Ensure laboratory area is maintained in a GMP state at all times while following all EHS and 5S guidelines. Will be expected to do laboratory walkthroughs to ensure area is suitable for hand off to oncoming shifts.

  • Actively contribute to a team setting within the laboratory and potentially with other work teams to increase efficiency, solve problems, generate cost savings, improve quality, and provide new product support, as needed.

  • Provide training and some work direction for assigned functional areas as required. Serve as a mentor to Sr. Support/Tech IV.

  • Operate and proactively maintain laboratory equipment. Ensure that equipment maintenance is properly documented in a timely manner.

  • Investigate deviations and write exception documents as required, utilizing problem-solving tools as needed.

  • Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, GLP, QSR, and cGMP regulations.

  • Support execution of validations for lab equipment, lab methods, or facility projects, as assigned.

  • May be required to generate, execute, and/or summarize special laboratory studies and/or review/revise of SOPs. Complete and/or direct completion of special project/protocol testing in a timely manner.

  • Assist Supervisor in updating department metrics and report shift activities, as assigned.

  • Ensure personal training requirements are met and that training records are current.

  • May perform disposal of hazardous waste.

Qualifications

  • Ability to handle multiple tasks concurrently and complete tasks in a timely manner.

  • Effective organizational skills and ability to plan and suggest resolutions to technical problems.

  • Demonstrated working knowledge of assays/equipment in functional area.

  • Computer literate and competent with a working knowledge of word processing and spreadsheets (such as Microsoft Office).

  • Must be detail-oriented, conscientious, and responsible.

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

  • Effective interpersonal communication. Must have effective verbal and written communication skills.

  • Can demonstrate the ability to guide people, encourage teamwork, and teach assays.

  • Working knowledge of applicable CTP/SOPs, EHS requirements, and application of cGMP/GDPs.

  • Good project management skills a plus.

  • Must be able to learn new computer systems and programs in a timely manner.

Education and/or experience

Typically requires bachelor's degree in chemistry, biological science, or other related technical field. 2+ years of related experience

Physical Demands

  • Must be able to lift, push, pull and carry up to 25 lbs and push up to 50 lbs.

  • In general, the position requires a combination of sedentary 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.

  • No make-up, jewelry, contact lenses, nail polish or artificial fingernails may be worn in the manufacturing environment.

  • Will be working in a loud area that requires hearing protection and other protective equipment to be worn.

  • 20/20 near vision required (corrected vision is acceptable)

  • Will work in a cold, wet environment

  • Will work around chemicals such as alcohol, acids, and alkalines that requires protective equipment

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

  • Must be able to work overtime as required.

  • May be required to work in a confined area. Inside and Outdoor working conditions.

  • Perform removal of hazardous waste.

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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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.