QA Specialist I
QA Specialist I
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Salary Not Disclosed
1 Vacancy
Job Description
The QA Technical Services Specialist is responsible for QA batch record review and disposition assuring thatbulk and finished products batch record documentation complies with Company policies regulatoryrequirements and current Good Manufacturing Practices. The function ensures the plant products meetspecifications and quality requirements. This will require interaction with other Quality AssuranceProduction Engineering IS and Administration personnel. The batch record review encompassesmanufactured batch records investigation of deviations exceptions and nonconformance reports.
Responsibilities:
Audit API and/or finished Drug Product electronic and manual (paper) batch records to assure compliance with applicable GMPs policies procedures and guidelines.
Evaluate potential discrepancies detected in batch records and determine the need for a corrective MES exceptions related to production batch record discrepancies per procedural requirements and work with other departments toevaluate the discrepancies to establish necessary actions to reduce timely disposition to manufactured products in the SAP system based upon result of testing and compliance with Regulatory Agency requirements. Prepare Certificate of Analysis Certificates of Compliance for API and/or finished Drug and verify batch information into the lot restriction management the batch record review package and label per the approved retention procedures.
Prepare reports related to Right the First Time Release Cycle Time Regulatory Audit requests and Product Quality Review. Revise procedures as and participate in plant weekly meetings for Shop Floor Control to discuss batch record status including discrepancies and/or issues that may impact batch accountability and responsibility of EHS performance and compliance.
Qualifications :
Bachelors Degree in Science preferably in Biology ChemistryBiotechnology or Engineering
Knowledge and experience in manufacturing of biotechnology products is needed and in aseptic processingis preferable. Knowledge of Quality regulations and standards affecting chemical biological or medicaldevices (i.e. Quality Systems FDA regulations etc.)- 2 years
Experience working in highly computerized Operations environments. Knowledge and experience in SAPLIMS MES and biotechnology manufacturing process is necessary. Incumbent must have excellent problemsolving analytical communication and interpersonal skills (1 year)
Support to other Quality Areas (Validation Compliance SQA among others)
Excellent oral and written communication skills in English and Spanish
Years of experience/education and/or certifications required:
BA Sciences
2 years experience in audits
Pharmaceutical Experience
What are the top 3-5 skills requirements should this person have
Audit experience
Pharmaceutical Experience
Quality Systems
Bilingual
What is a nice to have (but not required) regarding skills requirements experience educationor certification
Provide support on manufacturing area shift rotation
Candidates should be available for any shift and Shift Rotation 7/24
*Weil Group is proud to be an Equal Employment Opportunity Employer.*
Required Experience:
Unclear Seniority
Employment Type
Full Time
