Job: Quality Assurance Technician (Kelly; Owings Mills MD)
Quality Assurance Technician II
Job Code : BHJOB3479_227356
Job Type : Full Time
Category : Quality Assurance/Safety
Career Level : Experienced (Non-Manager)
Compensation : 0.00 Per Year
Location : Owings Mills MD US 21117
Job Description :
Kelly Scientific Resources currently has a six month contract opportunity for a Quality Assurance Technician II at a pharmaceutical company near Baltimore, MD.
Primary Role
Monitor and maintain compliance with regulatory requirements (cGMP and EU) and internal SOPs. Perform various sampling activities including maintaining control of samples and associated material documentation. Perform audits of documentation supporting those activities referenced above.
Responsibilities
* Monitor and maintain SOP and cGMP compliance regarding production, warehouse activities, and safety issues and provide observations reports.
* Continuous reviews of all systems and procedures (SOPs) for efficiency and regulatory compliance improvements. Write and revise SOPs as necessary.
* Maintain all QA-related paperwork and filing.
* Perform cleaning verification for room and equipment release for finished dosage batches.
* Perform training of new QA hires.
* Documentation audits include but are not limited to the following:
* Batch Records
* Room, Equipment, and Utility Logbooks
* Production cleaning records
* Protocols
* Training records
* General and Serialized Forms
* Room and Equipment Clearance checklist
* Audit materials to ensure appropriate use and SAP record accuracy.
* Perform product and material inspections as necessary.
* Collect manufacturing data for metrics
* Assist in the overseeing and auditing of controlled substances.
* Assist with investigations and implementation of CAPA related to SOP/cGMP issues.
* Be proficient in databases (i.e. SAP, LIMS, cME).
* Verify appropriate material usage and status.
* Sample raw materials and submit samples to Quality Control.
* Maintain sampling area and supplies.
* Prepare and submit authorizations for material reclassification/raw material disposition.
* Support regulatory and client audits.
Education & Experience Requirements
* Bachelor’s Degree required. Scientific discipline is preferred. Applicable experience may be substituted in lieu of degree.
* 2+ years of quality assurance or quality control experience in a pharmaceutical or regulated environment
* Working knowledge of GMP regulations
* Familiarity with ICH guidance documents
Other Requirements
* Ability to lift 50-lb. containers (23 Kg)
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