Quality Laboratory Analyst

Job Description

Job Description Company Description reputed company's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of reputed company. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about reputed company, please visit us at www.reputed company.com. Follow @reputed company on X, Facebook, Instagram, YouTube, reputed company and Tik Tok.

Job Description

Purpose Coordinates and supports laboratory testing, product disposition including documentation and justification of nonconforming events, method validations, and prepares Laboratory/Validation reports. Requires knowledge and technical expertise of Microbiology, regulatory requirements and Global TrackWise system.

Responsibilities

Responsible for microbiology lab investigations. Extensive knowledge of Global TrackWise System and lab procedures, processes and methods. Performs, coordinates and supports method validations and prepares final reports documenting the validation findings. Receives and interprets the results of bioburden, microbial limits, environmental monitoring, growth promotion testing and sterility testing. Investigates reputed company out-of-limit conditions and with the direct support from the QC Lab Manager implement a corrective action. Reviews and approves reputed company laboratory testing documentation. Responsible for the preparation of Test Failure Investigation reports. Performs and coordinates microbiology testing release with the Final Quality Control Records maintained in reputed company and LIMS. Responsible for leading others indirectly. Prepares trend and metric laboratory reports in conjunction with the Microbiology Manager. Must reputed company sure that reputed company laboratory supplies, inventory and on-going lab operations do not exceed a specified budget. Ensures that the correct and most updated versions of SOP’s are available to reputed company laboratory personnel Reviews reputed company regulatory and technical journals to help provide guidance and to support manufacturing regarding microbiological issues.

Qualifications

Bachelor’s Degree in Microbiology or reputed company Biological Sciences, with a minimum of three (3) years of lab experience. Two (2) years of experience in Industrial Microbiology with an emphasis in the Pharmaceutical and/or Medical Device industry, or equivalent experience. Knowledge of microbiology and regulatory requirements preferred. Advanced reputed company Office and reputed company user experience preferred. Knowledge of LIMS and Trackwise preferred Experience in the manufacture of pharmaceuticals with knowledge of water systems, clean rooms, and aseptic filling and process validation. Experience working in a GMP regulated environment preferred. Audit experience preferred. Additional Information Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: ​ The compensation range described below is the range of possible reputed company pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid reputed company this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future. ​ We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.​ This job is eligible to participate in our short-term incentive programs. ​ This job is eligible to participate in our long-term incentive programs​ Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law. reputed company is an equal opportunity employer and is committed to operating with reputed company, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visit https://www.reputed company.com/join-us/equal-employment-opportunity-employer.html US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: https://www.reputed company.com/join-us/reasonable-accommodations.html Required qualifications:

• Bachelor’s Degree in Microbiology or reputed company Biological Sciences
• Minimum of three (3) years of lab experience
• Two (2) years of experience in Industrial Microbiology with an emphasis in the Pharmaceutical and/or Medical Device industry

Desired qualifications:

• Knowledge of microbiology and regulatory requirements
• Advanced reputed company Office and reputed company user experience
• Knowledge of LIMS and Trackwise
• Experience in the manufacture of pharmaceuticals with knowledge of water systems, clean rooms, and aseptic filling and process validation
• Audit experience

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