eTeam ยท 5 hours ago
QA Documentation Assistant
Myerstown, PA
Contract
Onsite
Senior Level
5+ years expeTeam is seeking a QA Documentation Assistant to support quality assurance processes in compliance with good manufacturing practices. The role involves reviewing documentation, coordinating with QA staff, and ensuring compliance with specifications for packaging components.
Information Technology
Hiring Manager
Kalpana M
Responsibilities
Coordinate priorities with other QA or SQA staff to ensure top priority work is accomplished in timely fashion. May provide additional direction to contract labor support as needed
Review test results and documentation associated with the receipt and testing of packaging components. May accept/reject and perform usage decision (signature authority), and may initiate and maintain written and verbal communication with packaging material component suppliers for approval of new and revised specifications
Prepare and maintain databases as assigned which may include Approved Supplier Database, CofC Database, and AIDa (Global Audit Database), metal rejects, release chart, deviation reports, product storage statements, and product fill requirements
Gather and compile QA information, and Support investigations with batch record review (i.e. batch manufacturing and packaging records) for accuracy and completeness; May perform mathematical audit of calculations. Requires extensive communication with internal and external departmental staff and management to complete these tasks
Maintain records and documentation associated with complaint samples (i.e. log book, labels)
Write and update/revise SOPs in area of focus
Prepare and maintain internal Quality Principle Audit schedule, Dev@com entry and CAPA entry and follow up
Perform audits in production areas per internal Quality Principle Audits. Collaborate with Supervisors to provide direction on inspection criteria for line quality issues, CAPAs, etc
If assigned just to QA Doc Release:
Audit all manufacturing and packaging documentation to ensure compliance with all GMP regulations and CLIENT standards. Release bulk intermediates and package component materials to ensure timely release to meet production requirements
Coordinate priorities with Documentation Auditors to ensure top priority work is accomplished in timely fashion
Review production records (i.e. batch manufacturing, packaging records and MES production reports) for accuracy and completeness; perform mathematical audit of calculations; prepare and maintain batch jackets
Issue/Reconcile manufacturing and packaging documents for execution according to SOPs in timely manner to support production schedules
Issue/Reconcile QC laboratory documentation for execution according to SOPs
Support site practices for document control in issuance/reconciliation of working documents
File new labeling exhibits, specification sheets, expiration authorizations, and storage documentation master packaging orders in appropriate files
Coordinate testing/release of work in process with production, QA and SCM departments
Prepare and maintain essential databases, such as metal reject reports, QA product labels and release chart; copy and distribute data as needed
Maintain batch manufacturing record files according to storage procedures
Qualification
Required
High School degree or GED with at least 5 years of experience in document review/auditing role in a cGMP industry is required
Strong Personal Computer skills required; Microsoft software preferred
Previous experience using SAP, MES, or other automated inventory system is required
Must have excellent interpersonal skills, written and oral communication skills, and have demonstrated ability to work effectively in a team environment
Must have demonstrated leadership skills in audit/review of cGMP documentation & in various special projects
Must have demonstrated ability to have good interpretive judgment of records, accurate mathematical calculation skills, organizational skills, and legible handwriting is required
Physically able to lift up to 50 pounds
Preferred
College background and/or secretarial or administrative certifications a plus
Company
eTeam
eTeam is a staffing agency that also provides payrolling services.
501-1000 employees
H1B Sponsorship
eTeam has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (34)
2024 (205)
2023 (11)
2022 (7)
2021 (24)
2020 (25)
Funding
Current Stage
Late StageTotal Funding
unknown2023-12-04Acquired
Leadership Team
Swetta Bhatt
CEO APAC & India
Aanchal Thakur
Founder and Global Director-Strategic Accounts
Recent News
2025-11-19
2025-08-21
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