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BioPharma Career Opportunities - Apply Here

Pharmaceutical GMP Materials - Quality ,Logistics, Inventory & SOP Assurance
Pay: $28-$40.00+/hour
Hours: 1st, 2nd and 3rd shifts

The individual in this role will be part of a cohesive team responsible for producing GMP mRNA-based medicines for evaluation in human clinical trials. He/she will support the handling and processing of materials within manufacturing operations in accordance with established processes and procedures. The successful candidate will be able to document and communicate their operational observations clearly and efficiently. They will be curious to learn and able to demonstrate a high degree of working flexibly.

Here’s What You’ll Do:
§ Safely transport product, equipment and materials (buffers, drug substance) from the warehouse to designated areas in accordance with Standard Operating Procedures (SOP) and EH&S requirements in support of the manufacture of mRNA medicines
§ Assist manufacturing, QA and logistics colleagues in other activities as required
§ Strict adherence to current good manufacturing practices, standard operating procedures, and manufacturing documentation. Establish and follow written procedures for the clear and accurate documentation of equipment operation and process instructions, and of process data.
§ Receiving goods and materials through ERP management system, inspect and prioritize distribution of goods, materials, supplies and/or products ensuring accurate quantities and completing records.
§ Handling material ensuring compliance throughout CNC space
§ Transport materials, supplies and/or products. Transfers materials to and from Logistics and Manufacturing. Ensure accurate quantities are delivered.
§ Inventory Control: document all transactions/movements and perform physical inventory checks/reconciliations.
§ Other responsibilities include: proper storage, verification for accuracy, wipe down, maintaining required logs, records, security and safety.

Here’s What You’ll Bring to the Table:

§ AS Degree and/or BioWork Certification preferred; High school diploma or GED required
§ Experience in a highly-regulated industry, Pharmaceutical, medical device or cGMP related field
§ At least 1-year regulated manufacturing or material handling a plus
§ At least 1-5 years’ experience with SAP/ Oracle a plus
§ Maintain Cleanroom/Gown Certification
§ GMP experience is a plus. Good documentation practices are important.
§ Ability to collaborate fluidly with peers, supervisors and cross functional support groups required
§ Good organizational skills required
§ Ability to lift and move products
§ Proficient use of Microsoft Office (Microsoft Word and Excel).
§ Ability to work overtime when required
§ Collaborative, customer focused attitude

Technical Skills
Ø Kinetic-QCL, LAL Assay, chromogenic Limulus amebecyte lysate assay, kinetic chromogenic endotoxin analysis, Sterility, Bioburden, and Growth Promotion Testing
Ø Biological indicator analysis, Vitek Maldi-TOF
Ø testing cell lines
Ø Quality Control experience in a cGMP organization with a focus in Microbiology
Ø FDA, EU, USP, ICH guidelines and regulations
Ø Chromatography, TFF, single-use platforms
Ø Biotech/pharmaceutical, GMP/GLP environments preferred