eTeam
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Base pay range
$25.00/hr - $30.00/hr The QA Documentation Assistant Release is responsible for performing usage decisions on inspection lots of packaging components and intermediates, ensuring compliance with current Good Manufacturing Practices (cGMPs), Standard Operating Procedures (SOPs), and plant quality standards. This role involves reviewing in-process records, quality assurance test results, and assigning dispositions, as well as reviewing and assigning expiry dating for process inspection sheets used in finished goods packaging. Responsibilities Coordinate priorities with QA and SQA staff to ensure timely completion of top-priority tasks; provide direction to contract labor when required. Review test results and documentation related to packaging component receipt and testing. Perform acceptance/rejection and usage decisions (signature authority), and communicate with suppliers regarding new or revised specifications. Prepare and maintain essential QA databases, including Approved Supplier Database, CofC Database, AIDa (Global Audit Database), deviation reports, release charts, and product storage/fill requirements. Gather and compile QA information to support investigations, including detailed review of batch records (manufacturing and packaging) for accuracy and completeness. Perform mathematical audits as required. Maintain complaint sample documentation, including logbooks and labeling. Write, update, and revise SOPs relevant to QA documentation and release. Prepare and maintain internal Quality Principle Audit schedules, Dev@com entries, and CAPA tracking. Conduct production area audits and collaborate with supervisors on inspection criteria, CAPAs, and quality issues. Audit manufacturing and packaging documentation for compliance with GMP regulations and standards. Release bulk intermediates and packaging materials in line with production requirements. Coordinate workload with Documentation Auditors to meet production schedules. Review production records (batch manufacturing, packaging, MES reports) for completeness and accuracy; perform mathematical verification and maintain batch jackets. Issue and reconcile manufacturing, packaging, and QC laboratory documents per SOPs, supporting document control practices. File and maintain labeling exhibits, specification sheets, expiration authorizations, master packaging orders, and storage documentation. Coordinate testing/release of work-in-process materials with Production, QA, and Supply Chain. Maintain essential QA databases and distribute relevant data as needed. Ensure proper filing and storage of batch manufacturing records per site procedures.
Key Working Relationships
Collaborates with Supplier Quality Assurance, Manufacturing Sites, Supply Chain, Production, Warehouse, and QA personnel. Interacts with QA teams at Alcala, Bitterfeld, and site management at Myerstown. Works with cross-functional teams including PrT to issue documents, qualification reports, and testing records. Must be able to manage sensitive matters related to inspections and audits with professionalism.
Qualifications
High school diploma or GED with 5+ years experience in document review/auditing within a cGMP-regulated industry required. College background or administrative/secretarial certification preferred. Strong computer skills, with proficiency in Microsoft Office; prior experience with SAP, MES, or other automated inventory systems is required. Excellent interpersonal, written, and verbal communication skills. Demonstrated ability to work effectively in team environments and lead document audits/reviews. Strong analytical skills, with accurate mathematical calculation ability, sound judgment in record interpretation, strong organizational skills, and legible handwriting. Must be physically able to lift up to 50 pounds.
Seniority level
Associate
Employment type
Full-time
Job function
Quality Assurance, Manufacturing, and Supply Chain
Industries
Pharmaceutical Manufacturing
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$25.00/hr - $30.00/hr The QA Documentation Assistant Release is responsible for performing usage decisions on inspection lots of packaging components and intermediates, ensuring compliance with current Good Manufacturing Practices (cGMPs), Standard Operating Procedures (SOPs), and plant quality standards. This role involves reviewing in-process records, quality assurance test results, and assigning dispositions, as well as reviewing and assigning expiry dating for process inspection sheets used in finished goods packaging. Responsibilities Coordinate priorities with QA and SQA staff to ensure timely completion of top-priority tasks; provide direction to contract labor when required. Review test results and documentation related to packaging component receipt and testing. Perform acceptance/rejection and usage decisions (signature authority), and communicate with suppliers regarding new or revised specifications. Prepare and maintain essential QA databases, including Approved Supplier Database, CofC Database, AIDa (Global Audit Database), deviation reports, release charts, and product storage/fill requirements. Gather and compile QA information to support investigations, including detailed review of batch records (manufacturing and packaging) for accuracy and completeness. Perform mathematical audits as required. Maintain complaint sample documentation, including logbooks and labeling. Write, update, and revise SOPs relevant to QA documentation and release. Prepare and maintain internal Quality Principle Audit schedules, Dev@com entries, and CAPA tracking. Conduct production area audits and collaborate with supervisors on inspection criteria, CAPAs, and quality issues. Audit manufacturing and packaging documentation for compliance with GMP regulations and standards. Release bulk intermediates and packaging materials in line with production requirements. Coordinate workload with Documentation Auditors to meet production schedules. Review production records (batch manufacturing, packaging, MES reports) for completeness and accuracy; perform mathematical verification and maintain batch jackets. Issue and reconcile manufacturing, packaging, and QC laboratory documents per SOPs, supporting document control practices. File and maintain labeling exhibits, specification sheets, expiration authorizations, master packaging orders, and storage documentation. Coordinate testing/release of work-in-process materials with Production, QA, and Supply Chain. Maintain essential QA databases and distribute relevant data as needed. Ensure proper filing and storage of batch manufacturing records per site procedures.
Key Working Relationships
Collaborates with Supplier Quality Assurance, Manufacturing Sites, Supply Chain, Production, Warehouse, and QA personnel. Interacts with QA teams at Alcala, Bitterfeld, and site management at Myerstown. Works with cross-functional teams including PrT to issue documents, qualification reports, and testing records. Must be able to manage sensitive matters related to inspections and audits with professionalism.
Qualifications
High school diploma or GED with 5+ years experience in document review/auditing within a cGMP-regulated industry required. College background or administrative/secretarial certification preferred. Strong computer skills, with proficiency in Microsoft Office; prior experience with SAP, MES, or other automated inventory systems is required. Excellent interpersonal, written, and verbal communication skills. Demonstrated ability to work effectively in team environments and lead document audits/reviews. Strong analytical skills, with accurate mathematical calculation ability, sound judgment in record interpretation, strong organizational skills, and legible handwriting. Must be physically able to lift up to 50 pounds.
Seniority level
Associate
Employment type
Full-time
Job function
Quality Assurance, Manufacturing, and Supply Chain
Industries
Pharmaceutical Manufacturing
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