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USA - Quality Control Analyst I
1978 West Winton Avenue Hayward, CA 94545 US
Job Description
*depending on experience
Summary:
• Conduct environmental monitoring of ISO 5, 7, 8, and 9 cleanrooms at manufacturing facilities along with Water collection. Support Microbiology analysis such as raw materials, in-process and finished goods products samples at manufacturing facility.
• Conduct Microbiological analysis on raw materials, initial, in-process and final products, and samples collected from the environmental monitoring programs at manufacturing facility.
• Testing as required supporting Endotoxin testing, Bioburden analysis, growth promotion, Will be required to read microbial plates and interpret test results.
• QC Data entry in Sample manager- LIMS
• Complete all testing, including special project / protocol testing in a timely and appropriate manner.
• Perform equipment maintenance and calibrations as required.
• Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, GLP, QSR and cGMP regulations.
• Perform/or support all NCRs, CAPAs, and LIRs and be the point of contact for other departments for updates.
• Participate in functions involving teams, which impact production, increase efficiency, solve problems, generate cost savings, and improve quality.
• Perform laboratory and manufacturing audits as required. Audit and update, as required, plant/lab SOPs.
• Ensure Environmental Monitoring area is always maintained in a GMP state while following all EHS and 6S guidelines.
• Flexibility in performing other duties, as assigned, or as business needs require.
• Works and communicates effectively and professionally with others inside and outside the company.
• Weekend work may be required as needed to meet production timeline schedules.
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.
• Demonstrates some knowledge of assays/equipment in functional
area. Computers literate and competent with a general knowledge of
word processing and spreadsheets (such as Microsoft Office).
• Proficient use of laboratory equipment and tools. Must be detail oriented, conscientious, and responsible. Must have effective verbal and
written communication skills. Some knowledge of applicable CTP/SOPs,
EHS requirements, FDA Regulations application of CGMP/GDPs.
• Must be able to learn about new computer systems and programs in a timely
manner. Must be able to learn new computer systems and programs in a
timely manner.
Education and/or Experience
• B.S. degree in Microbiology, Biology; minimum 1-2-year experience in Pharmaceutical/Medical Device industry preferred.
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it’s from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.
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