Senior Specialist Quality Control, Microbiology - Day Shift
About The Position
Quality develops and implements quality policies, procedures, and processes to ensure products and services comply with regulatory standards and specifications. Quality Control is responsible for the analysis or inspection of materials, components, products or processes for compliance with specifications and standards. This role applies working knowledge in the application of concepts, principles, and technical capabilities to perform varied tasks on projects of moderate scope and complexity. The Senior Specialist identifies possible solutions to a variety of technical problems and takes actions to resolve them, applying judgment within defined parameters. They receive general guidance and may receive more detailed instruction on new projects, with their work reviewed for sound reasoning and accuracy.
Requirements
- Bachelor’s degree in Microbiology/Biology or related field preferred or equivalent industry experience.
- Minimum 2-4 years in the pharmaceutical or biotechnology industry with emphasis in one of the following areas preferred: QC microbiology, environmental monitoring, critical systems monitoring, quality control, aseptic manufacturing.
- Competent in the use of various computer programs such as Outlook, Word, Excel, and PowerPoint.
- Excellent communication, documentation, and organization skills.
- General knowledge of industry regulations pertaining to cGMP.
Nice To Haves
- Experience in authoring documentation such as SOPs, test methods, change controls, CAPAs, deviations, and laboratory investigations is desirable.
Responsibilities
- Perform various microbiological testing procedures adhering to Manufacturing/QC batch records, protocols, and/or test methods.
- Perform environmental monitoring in controlled and classified manufacturing and testing areas.
- Work with project managers, manufacturing, and QA to ensure timely testing of samples and release of products.
- Inform management of Out of Specification/Out of Trend results and other non-conformances.
- Participate in investigations and other related studies.
- Participate in validation, calibration, and troubleshooting of various types of equipment and instruments including proactive resolution of operating issues.
- Adhere to environmental health and safety requirements and procedures.
- Review, analyze, interpret, trend, and report test result data.
- Participate in general laboratory upkeep.
- Adhere to Good Documentation, Laboratory, and Manufacturing Practices.
- Support department compliance and productivity goals.
Benefits
- Medical, dental and vision coverage
- Paid time off plan
- Health savings account (HSA)
- 401k savings plan
- Access to wages before pay day with myFlexPay
- Flexible spending accounts (FSAs)
- Short- and long-term disability coverage
- Work-Life resources
- Paid parental leave
- Healthy lifestyle programs
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What This Job Offers
Job Type
Full-time
Career Level
Senior
