Sr. QC Associate

The SR QC Associate is assigned to QC functional or technical area in either HPLC/Client, Potency testing (Bioassay and Binding assays), Residual Impurities, Physicochemical/Drug Product, Microbiology/Environmental monitoring, Raw Materials/Cleaning validation/verification and Packaging testing. This role executes and coordinates analytical testing of bulk drug substances and drug products in a multi-product facility as well as executes and coordinates Raw Material sampling and testing and sampling of clean rooms (as applicable).

Duties:

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• The SR QC Associate is assigned to QC functional or technical area in either HPLC/Client, Potency testing (Bioassay and Binding assays), Residual Impurities, Physicochemical/Drug Product, Microbiology/Environmental monitoring, Raw Materials/Cleaning validation/verification and Packaging testing.
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• This role executes and coordinates analytical testing of bulk drug substances and drug products in a multi-product facility as well as executes and coordinates Raw Material sampling and testing and sampling of clean rooms (as applicable).
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• The SR QC Associate coordinates routine-maintained activities and is responsible for routine quality and compliance activities (authoring of test methods, specs, plans, reports, forms, SOPs).
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• This role performs duties under limited supervision and according to standard operating and QC procedures.
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• Trains other associates and technicians on methods and processes.
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• Executes independently, with adequate training, three to five (3-5) analytical testing methods with different analytical principles under minimum oversight by qualified staff.
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• Manages and reviews fundamental tasks such as but not limited to buffer prep, TCU maintenance, and cleaning.
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• Identifies and implements fundamental improvements to lab processes compliance activities.
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• Responsible for routine quality and compliance activities (authoring of test methods, forms, SOPs).
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• Documents work according to cGMP and cGDP.
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• Adheres to established regulations and follows cGMP established by site.
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• Reports abnormalities and deviations in a timely and accurate manner.
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• Adheres to safety standards and identifies unsafe situations / habits and escalates appropriately.
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• Maintains and improves lab areas according to predefined standards (5s).
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• Maintains own training within compliance and trains other technicians and associates on operations upon completion of trainer qualification.
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• Conduct group training on compliance topics and scientific principles as needed.
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• Performs testing and review within several different analytical technologies.
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• Reviews and trends analytical data and compliance processes to identify out of trends.
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• Authors routine compliance documents.
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• Identifies process anomalies and areas for improvement for operations.
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• Provides compliant and smart solutions for moderately complex methods and testing issues.
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• Coordinates work within the team and cross functionally.
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• Reviews data and identifies discrepancies and ensures they are properly investigated, assessed and appropriate root causes are put in place.
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• Represents team in matrix team meetings with cross functional team members to resolve issues and produce solutions.
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• Trains other associates and technicians on methods and compliance.
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Skills:

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• Previous QC Experience preferred.
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• Experience with performing analytical methodologies within different scientific principles relevant to Biopharmaceutical manufacturing.
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• Ability to concentrate on detail-oriented work in a complex technical setup with a Quality and Right the first-time mindset.
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• Strong understanding of analytical chemistry and/or analytical testing as it applies to biopharmaceuticals.
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• Proven experience with technical review, analysis, and interpretation of scientific data.
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• Strong written and verbal communication skills.
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• Experience with computer-based systems and ideally experience with process control systems
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• Previous experience reading and understanding SOPs and/or methods and document work in a written format applying cGMP/GDP standards.
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• Ability to work as part of a high performing team and collaborate effectively with staff.
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• Proficiency in 3-5 analytical methodologies within different scientific principles, including technical review, interpretation and trending as needed.
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• Strong understanding of analytical chemistry and/or analytical testing as it applies to biopharmaceuticals.
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• Strong focus on execution of non-routine analytical methods or processes.
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• Strong technical knowledge in analytical methods.
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• Ability to work independently with very little supervision.
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• Champions problem resolution.
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• Knows when to escalate to line management.
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• Strong technical knowledge in analytical methods.
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• Work independently with very little supervision, champions problem resolution, knows when to escalate to line management, and provides compliant and smart solutions for moderately complex method and testing issues.
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Education:

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• High School Diploma with six (6) years of experience in cGMP regulated industry or equivalent.
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• OR, Associate Degree with four (4) years of experience in cGMP regulated industry or equivalent.
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• OR, Bachelor's Degree in a science or engineering related field with two (2) or more years of experience in cGMP regulated industry or equivalent.
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Schedule Notes:1st Shift: Mon-Fri, 8AM-5PM