Position Summary:
The Quality Control Associate Scientist will serve as the primary coordinator for the inventory management and requalification of critical ELISA reagents within the Quality Control (QC) department. The main responsibility is to ensure the integrity and availability of ELISA critical reagents by leading equivalency studies and authoring comprehensive reports for USDA submission. This role also supports ELISA reference requalification and will coordinate new reference qualification testing with cross-functional groups.
In addition to ELISA reagent management, this team contributor role supports QC compliance by reviewing executed bench records, ensuring scheduling adherence, performing periodic Standard Operating Procedures (SOP) reviews to ensure alignment with regulatory guidelines, and assist with team action items and laboratory investigation reports. The colleague will be trained to perform testing and is expected to maintain in-depth knowledge of assay performance. The successful candidate will assist Team Leader in directing and prioritizing tasks to ensure accurate, timely completion of tests and records, supporting reliable results and timely product delivery.
Position Responsibilities
- Possesses experience with project management within the laboratory setting and consistently ensures timely completion of deliverables with little oversight.
- Maintains a thorough understanding of assay performance and trending, proactively monitoring results, and ensuring the integrity of all critical reagents with minimal direction from team leader.
- Experience with inventory management of laboratory reagents, preferably ELISA critical reagents.
- Strong scientific writing skills to author comprehensive technical reports for regulatory submission (e.g., USDA).
- Familiarity with ELISA methodology and reference qualification/requalification processes.
- Demonstrates ability to work collaboratively with cross-functional teams.
- Audit/review bench records according internal and regulatory guidelines to ensure schedule adherence.
- Provide backup assistance in testing in-process samples, blended vaccines and final containers for all applicable assays utilizing good aseptic practices and QC equipment with no supervision.
- Write investigation reports, as necessary, utilizing Method I and DMAIC processes.
- Prepares and maintains documentation in compliance with cGMP guidelines.
- Author/review Standard Operating Procedures (SOPs) and Standard Methods (SMs) to meet periodic review timelines and ensure compliance.
Education and Experience
- High school education or GED required.
- BA/BS education in the Sciences or Business disciplines preferred or at least 6 years’ experience in related field.
Technical Skills
- Ability to plan, organize, and manage multiple projects in a laboratory setting, ensuring deliverables are completed on time with minimal supervision.
- Understanding of ELISA techniques, including reference qualification and requalification processes
- Knowledge of USDA and EU regulatory requirements, with the ability to maintain compliance as guidelines evolve. Ability to effectively work with diverse teams across departments to achieve project and organizational goals.
- Excellent organizational skills.
- Willingness to positively embrace change and flexibility in adjusting to changing priorities.
- Strong attention to detail, ability to work well independently and as part of a team, and to work effectively with people at all levels within the organization.
- Ability to trouble-shoot problems and implement corrective action and proactively seeks out opportunities for improvements and takes action.
- Excellent written and oral communication skills.
- General knowledge of the following software programs: Word, Excel, and PowerPoint
- High level of understanding of multiple technologies and/or assays within the workgroup
Physical Position Requirements
- Must be able to walk, sit, or stand for long periods of time.
- Must be able to reach above shoulder level, bend/stoop, kneel, push/pull, and handle/grip frequently.
- Must be able to work scheduled 40 hours with the ability to work overtime as needed.
- Frequent lifting and carrying of 5 to 25 lbs.
- Regular reaching, bending, stooping, and twisting.
- Repetitive motion and substantial movement of the wrists, hands, and/or fingers.
Full timeRegularColleague
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