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Company

Original Job Post

BioSpace · 2 days ago

Senior Associate Quality Control, Sample Management and Stability

Holly Springs, NC

Full-time

Onsite

Senior Level

4+ years exp

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Comp. & Benefits

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Responsibilities

Lead the QC Support team by developing/maintaining processes and procedures for sample handling and storage.

Assist in the development cGMP system for incoming and outgoing samples.

Assist in the development of cGMP system for stability samples. Preparing protocols and defining the process by which to stage/load samples and handle pulls.

Develop/oversee monitoring system for sample and stability storage units.

Own and handle Deviation, CAPA and Change Control records to support Quality Control.

Work collaboratively with site teams to establish work order and PM system for laboratory equipment.

Review validation documents to support equipment and computerized system onboarding for sample management lab.

Author, revise and review documents and reports including but not limited to SOPs, test methods, safety assessments, trend reports, qualification/validation summary reports, technical reports, method assessments, technical assessments, microorganism assessments.

Assist with procurement activities for consumables and critical reagents for lab start up.

Participate in audits, initiatives, and projects that may be interdepartmental or global in scope.

Support routine activities over the weekends and public holidays as required.

Qualification

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Quality ExperienceChemistryBiochemistryPhysicsChemical EngineeringLaboratory ExperienceGMPAnalytical TestingLIMSLMES/CIMSComplianceTechnical WritingEquipment ValidationMethod ValidationChange ControlProblem-SolvingCommunicationTeamwork

Required

High school/GED + 4 years of Quality experience OR

Associates + 2 years of Quality experience OR

Bachelors + 6 months of Quality experience OR

Master's

Preferred

Degree in a related scientific field such as Chemistry, Biochemistry, Physics or Chemical Engineering.

4+ years of relevant laboratory experience in the GMP commercial manufacturing environment within the pharmaceutical or biopharmaceutical industry and analytical testing experience preferred.

Proficient in the use of LIMS & LMES/CIMS.

Knowledge of related regulatory/industry considerations, compliance issues and/or scientific discovery.

Strong written and verbal communication skills including technical writing and presentation.

Experience with equipment and method validation, verification, and transfer including the change control process.

Interact effectively with a variety of communication and working styles and ability to work well in teams.