Senior Specialist 1, Quality Control Lab Support
About The Position
The Senior Specialist 1, Quality Control Lab Support works under moderate supervision, supporting and participating in QC activities related to investigations, deviations, OOS/OOT, CAPAs, and Change Controls. This role assists in creating and maintaining GMP documents and processes, collaborating with stakeholders and QA. This role contributes to customer contact and CLO communication to support QC capabilities in delivering materials and results. This role helps ensure QC compliance with policies and procedures. This role participates in project management and process improvement initiatives, developing skills in risk assessment. The role requires the ability to work effectively both independently and as part of a team, with growing cross-functional collaboration.
Requirements
- Bachelor’s degree in science, preferably Chemistry, Biochemistry, Microbiology, Biology, or Life Sciences relevant scientific discipline with 2+ years of relevant experience OR
- Master’s degree in science, preferably Chemistry, Biochemistry, Microbiology, Biology, or Life Sciences relevant scientific discipline with 0 years of relevant experience
- 1- 3 years relevant experience, experience in a GMP environment
Nice To Haves
- Experience with KNEAT software
- Experience qualifying analytical instruments
Responsibilities
- Initiates and authors deviations, CAPA’s, and change controls for the functional groups within QC
- Initiates and supports actions for implementation of solutions, process improvements and CAPAs
- Participates in customer interactions to gain exposure to topics such as changes, deviations, or other issues and gathers data for status overviews and reports deviations upon completion of training and observation
- Reviews and updates stability protocols, sample plans, and specifications related to Drug Substance and Drug Product updates for controlled GMP documents related to sample plans and specifications
- Coordinates technical projects and performs problem-solving learning to apply analytical and QC improvement methodologies
- Participates in cross-functional team meetings to gain exposure to QC's role in various business processes
- Supports QC laboratories in method troubleshooting efforts by collecting data and assisting team members
- Owns changes in support of QC laboratories through the change control processes, and compliance-related documentation
- Performs continuous improvement activities by developing awareness of quality systems and identifies potential areas for improvement
- Provides recommendations to management on KPI’s as needed to evaluate the changes made
- Assists team members in Contract Laboratory (CLO), communication roles, learning about issues such as OOS's and deviations and compiles data for performance and status reports Interacts with clients as needed to support change controls and deviations
- Documents sample receipt, storage, and movement in Labware LIMS and/or internal sample chain of custody forms or logbooks
- Identifies and escalates sample issues to appropriate parties
- Performs other duties, as assigned
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
501-1,000 employees
