We are seeking a dedicated professional to manage product inspections and quality control audits, including first article assessments and calibration tasks. You will be tasked with evaluating flat blank layouts, conducting out-of-box audits, and sampling incoming raw materials and components. Your work will involve managing material purges, verifying that all raw, in-process, and finished goods align with our quality benchmarks, and maintaining essential quality alert documentation.
Key Responsibilities
- Execute dosimetry measurements and daily lab operations, such as releasing and delivering dose trays, generating reports, and maintaining cleanliness.
- Carry out microbiological evaluations, including assessments for bioburden, endotoxin, and media.
- Utilize viable air samplers and specialized laboratory instrumentation to perform environmental monitoring.
- Support the team by assisting with investigations related to corrective actions.
- Manage environmental excursions within controlled settings to ensure operational integrity.
- Identify, elevate, and analyze out-of-specification results concerning microbial testing, environmental monitoring, and dosimetry.
- Maintain precise and comprehensive laboratory records in strict adherence to Good Documentation Practices.
- Demonstrate effective organizational and time-management capabilities to transition between various duties seamlessly.
- Foster collaboration across departments by utilizing strong interpersonal and communication skills.
- Apply foundational computer literacy, specifically within the Microsoft Office suite.
- Leverage experience with Laboratory Information Management Systems (LIMS) if applicable.
- Perform mathematical calculations involving fractions, decimals, percentages, and whole numbers across various units of measure.
- Interpret and follow moderately complex work instructions and procedural documents.
- Apply critical thinking to troubleshoot issues and independently analyze test data.
- Utilize knowledge of regulatory standards such as GLP, GMP, USP, and ISO.
- Operate with a high degree of autonomy once the initial training period is complete.
Required Background
- Possession of a High School Diploma, GED, or equivalent technical training.
- A minimum of four years of relevant experience, specifically within a microbiology setting.
- Interviews are available for immediate scheduling.
- This position plays a critical role in supporting a major pharmaceutical product line within a high-speed environment.
- There is a significant potential for this role to transition into a permanent position.
Equal Opportunity Statement
All qualified candidates will be considered for this position regardless of race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or genetic information.