Vendor Quality Control Analyst jobs in Gainesville, FL

A career at Resilience is more than just a job - it's an opportunity to change the future.

Resilience is a technology-focused biomanufacturing company that's changing the way medicine is made. We're building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need.

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Position Summary:

The Senior Analyst, Quality Control will partner and collaborate with the Analytical Development and QC operations teams to ensure that all required method transfers, qualifications and validations are performed, meeting all partner needs in compliance with standard operating procedures and testing methods. Specific activities include authoring/executing/review of study design, protocols and reports associated with qualification/validation/transfer studies.

This position is a first shift role and reports to the Head of QC, Method Lifecycle and Stability. The position will be in our Alachua, FL facility.

Job Responsibilities:

• Senior Analyst, Quality Control activities to include, supporting method selection and development to leading method transfer, qualification and validation, monitoring routine use, leading change controls and retirement of the method

  • Transfer/qualification/validationactivities using protein-based assays, molecular methods, and cellular assays

  • Author and/or review method transfer, qualification and validation protocols and reports.

  • Collaborate with Analytical Development personnel to ensure methods are suitable for transfer to QC fortransfer/qualification/validation.

  • Assists in developing, troubleshooting, optimizing complex biological QC procedures according to regulatory requirements.

  • Collaborate with QC Product Testing personnel to ensure analysts are trained on newlytransferred/qualified/validatedprocedures.

  • Analyze, document, and report experimental data in accordance to Resilience requirements

  • Collect/evaluate data trends to ensure qualified/validated methods remain in a state of control.

  • Present/discuss data in client facing meetings

• Provide support to the QC Operations team as needed

  • Performing immunoassays, cell-based assays, molecular biology assays and virology testing in support of product release, in-process testing and stability

  • Train analysts on analytical techniques

  • Troubleshoot assay failures

  • May require occasional early morning, late evening, and / or weekend work

• May require occasional early morning, late evening, and / or weekend work.

• Other activities as assigned

Minimum Qualifications:

• Experience performing Protein based assays, Cell Assays and Ligand binding assays.

• Knowledge of Analytical Method Lifecycle requirements with previous experience in method transfer, qualification and validation

• Experience with cGMPs applicable to the pharmaceutical industry.

• Strong verbal / written and interpersonal communication skills as a team player and willing to work in an environment where individual initiative, collaboration and accountability are valued.

• Analytical problem-solving and troubleshooting skills.

• Adaptable and flexible in response to a dynamic operating environment

Preferred Qualifications:

• BS in a Biological Science (Biochemistry, Microbiology, Immunology, Molecular Biology, Virology), or related field. MS preferred.

• Familiarity with ELISA type assays (colorimetric, fluorometric, chemiluminescent, etc.) and/or qPCR and ddPCR molecular assays; virology methods such as TCID50, plaque, FFU. Experience with Capillary Electrophoresis and/or HPLC a plus.

• This level of technical proficiency is typically gained through a degree in a scientific discipline and 5 years of relevant experience.

Role/Site Specific Requirements:

This position may also include the following:

Physical work

• This role is primarily a non-Sedentary role. This can include climbing, kneeling, repetitive motion, temperature changes, and exerting up to 100 pounds of force to move objects.

Visual acuity (such as: working with data & figures, viewing computer terminal, extensive reading, operating machinery, operating motor vehicles, general observations of facilities, etc.)

Participation in an occupational health program (which can include medical assessment, surveillance, vaccination, and testing)

Use of personal protective equipment (which can include respirators, Personal Air Purifying Respirators [PAPR], gowns, gloves, face protection, other barrier equipment, etc.)

Exposure to the following:

• Use of personal protective equipment (which can include respirators, Personal Air Purifying Respirators (PAPR), gowns, gloves, face protection, other barrier equipment, etc.

• Handling, managing, disposing hazardous and non-hazardous waste (which can include: chemicals, universal and e-wastes, oil, aqueous wastewater, etc.), inclusive of exposure to bloodborne pathogens

• Working in BSL-2/3 laboratories & production rooms, waste holding areas, or other facilities where biological hazards and hazardous chemicals may be stored or handled.

• Packaging, transporting, and shipping of infectious or potentially infectious substances

The items described here are representative of those that must be met to successfully perform the essential functions of this job.

Resilience is an Equal Employment Opportunity Employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender perception or identity, national origin, age, marital status, protected veteran status, disability status, physical or mental disability, genetic information, or characteristic, or other non-job-related characteristics or other prohibited grounds specified in applicable federal, state, and local laws. Requests for reasonable accommodation can be made at any stage of the recruitment process.