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Quality Control Analyst
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. Additional testing includes LAL, pH, TOC and Conductivity.
Essential Duties and Responsibilities
- Perform microbial and particulate monitoring of clean rooms throughout LA facility. Work under some Supervision. May be responsible for overseeing daily work flow of assigned area.
- Testing as required supporting 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. ECR, DCR) when required and complete them in a timely manner. Assure SOPs are updated; prepare and update as determined.
- Identification and issuance of Alert/OOL forms for out of limit results. May be required to conduct investigations 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 walk throughs 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.
- Provide training and some work direction for assigned functional areas as required.
- 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.
- May be required to generate, execute, and summarize special laboratory studies.
- Drive Lean principles such as 5S throughout daily work activities.
- Ensure personal training requirements are met and that training records are current.
- May perform disposal of hazardous waste.
- Other duties as assigned by departmental management.
- 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 microbiology, chemistry, biological science, or other related technical field. Some related work experience preferred.
- Must be able to lift, push, pull 50 lbs and carry up to 25 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.
- 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 require protective equipment.
- 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. Inside and Outdoor working conditions.
- Some Clean Room and cool/hot storage conditions.
- Perform removal of hazardous waste.
This job posting excludes CO applicants.
EEO Verbiage for US Reqs
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.