Shire Sr. Quality Assurance Specialist - Microbiology in Los Angeles, California
Essentially function as a primary operations delegate to the Microbiology Laboratory Manager. Successfully perform all the primary activities as defined in the Microbiology Laboratory Supervisor job position. In addition, responsible for the overall logistics of the Microbiology lab across all shifts (e.g. oversight of scheduling, driving completion of lab commitments, develop/monitor/analyze operational metrics, audit lead, problem solving, approve investigations, 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.
Essential Duties and Responsibilities
Lead ongoing daily department activities across all shifts for the Microbiology 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 Microbiology Lab across all shifts, including scheduling, training, PR support, Investigation support, etc.
Use Lean tools and make recommendations to improve operational efficiency and throughput. Make recommendations on Lean Lab Improvements.
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, be a project manager to lead multiple process/product improvement projects. These projects may be executed through CAPA, QWT, Kaizen, Risk Assessments or other focus groups, design of experiments, validations, studies, data generation and analysis, report preparation, presentations, and/or change control.
Inspection involvement - Primary audit escort for the Microbiology 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. Participate in QC Supplier Quality audits.
Lead in the development of customer awareness and support activities for Microbiology, and assist and drive such activities throughout the shifts.
Operational liaison with various customers (e.g. Manufacturing BUs, RLDD, Hayward, Global Microbiology 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 Microbiology Laboratory Manager in his/her absence.
Prepare, review and revise, as required, CTPs and SOPs. Write memos, assessments, reports, protocols, CPAs and other appropriate documentation as they pertain to Microbiology operations and procedures. Lead or support problem solving efforts for investigations and process improvements.
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.
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 supervisors and analysts.
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. Data Integrity experience a plus.
Demonstrates basic project management skills, must be able to lead projects.
Proficient with wide variety lab application software.
Expert in applying QLP or Baxter Technical problem-solving tools; Lean Instructor or CAPA Investigator Certified a plus. Six Sigma Training/Certification is a plus.
Education and/or experience
Typically requires a bachelor's degree in science (Microbiology/Biology preferred), engineering or other related technical field.
5+ years of related experience.
Must be able to lift, push, pull and carry up to 25 lbs.
In general, the position requires a combination of sedentary work, standing 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.
Will work in a cold, wet environment for investigational purposes.
Must be able to work multiple shifts, including weekends.
Must be able to work overtime as required. (only for non-exempt positions)
May be required to work in a confined area for investigational purposes.
Some Clean Room and cool/hot storage conditions for investigational purposes.
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