QA Specialist II, Operations
Posting ID: JP-002016626
Responsible for executing and providing guidance to others on Quality Assurance processes associated with batch record review and product dispositions processes for drug products manufactured by company and contract manufacturing organizations, incoming raw material, component, and third party intermediate product inspection review and disposition processes, product and facility support documentation review and approvals. Routine participation in Quality Operations floor support activities such as area clearances and product inspections, inventory management system entries and QA system support and other support activities such as metrics tracking, training, and cross-functional communications. The above is the permanent job description. This contractor needs to have the below at a minimum for this role: Must haves: • Review and approve GMP-related documents (i.e. manufacturing and quality control records, stability results, environmental monitoring, calibration and maintenance reports, etc.) pertaining to chemical intermediates APIs, drug substances, and drug products for accuracy, completeness, and compliance with UT policies, procedures, and cGMPs • Perform Quality Assurance (QA) functions to include but not limited to area clearances, in-process checks, raw material releases, logbook reviews to support manufacturing activities
Quality assurance, Gmp, Batch record, Document control, Environmental Monitoring, CAlibration, stability, Qa, Cgmp, Batch record review, Manufacturing records, quality records, maintenance report, Drug substance, API, raw material release, Bulk Label Issuance, AQL Inspection, SAP, Mastercontrol, LIMS, AQL
Top Skills Details:
Quality Assurance GMP Batch Record Review Environmental Monitoring Solution Prep
Additional Skills & Qualifications:
• Review and approve GMP related documents (i.e. manufacturing and quality control records, stability results, environmental monitoring, calibration, and maintenance reports etc.) pertaining to chemical intermediates APIs, drug substances and drug products for accuracy, completeness, and compliance with UT policies, procedures, and cGMPs • Perform Quality Assurance (QA) functions to include but not limited to: area clearances, in-process checks, raw material release, logbook reviews, and AQL Inspections to support manufacturing activities • Create, revise and approve labels in support of manufacturing operations • Review and collaborate on draft Batch Records, Protocols, Summary Reports, Standard Operating Procedures, Raw Material Specifications, etc. • Author SOPs related to Quality Operations activities, as assigned • Performs Internal and CMO batch record review and release for clinical and commercial products, including all equipment prep, intermediate products and solution preparation, as applicable • Perform review of Solution Preparation Records and Column Packing Records • Participate in quality system project initiatives • Perform monthly logbook reviews • Process rejected lots and product identified for destruction • On-site contact for manufacturing and quality control personnel related to batch record documentation, manufacturing labeling, and other quality operations responsibilities • Provide support for SAP Master Data changes • Review external product temperature excursions • Provide documentation and SME support for regulatory inspections. (FDA, MHRA, etc) • Support CPV and APR processes by providing requested data as needed • Participate in quality system project initiatives
We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffing® Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at Aerotek.com.
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
Recruiter: Michael Camiolo