Quality Assurance (Pharmaceuticals)

Dexian; Myerstown (PA); Sur place; USD 41 328 - 48 216; Temps partiel

Résumé du poste

A leading staffing provider is seeking a Quality Assurance professional to perform document reviews and audits in a pharmaceutical setting. Responsibilities include ensuring compliance with GMP standards, coordinating with QA teams, and maintaining quality databases. Candidates should have at least 5 years of experience in a relevant role, possess strong interpersonal skills, and be able to lift up to 50 pounds. This role offers a contract position with competitive pay.

Qualifications

• 5+ years in a cGMP document review/auditing role.
• Strong PC skills, preferably with Microsoft software.
• Ability to physically lift up to 50 pounds.

Responsabilités

• Audit documentation for compliance with GMP.
• Coordinate with QA and contractors for timely work.
• Prepare and maintain essential QA databases.

Connaissances

Document review/auditing

SAP

Microsoft applications

Interpersonal skills

Communication skills

Mathematical calculation

Formation

High School degree or GED

Outils

SAP

MES

Description du poste

This range is provided by Dexian. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$30.00/hr - $35.00/hr

Direct message the job poster from Dexian

QA Doc/Release

• In QA Doc/Release, performs usage decisions on inspection lots of packaging components, and intermediates as to conformance to current good manufacturing practices (cGMPs), standard operating procedures (SOPs), and plant quality standards.
• Review in-process records and quality assurance test results for compliance with specifications and assign disposition.
• Review and assign expiry dating to process inspection sheets used for finished goods packaging.

Job 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 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 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

Qualifications and Competencies

• High School degree or GED with at least 5 years of experience in document review/auditing role in a cGMP industry is required.
• College background and/or secretarial or administrative certifications a plus.
• 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.

Seniority level

Not Applicable

Employment type

Contract

Job function

Quality Assurance, Accounting/Auditing, and Science

Industries

Pharmaceutical Manufacturing, Retail Pharmacies, and Biotechnology Research

Dexian is a leading provider of staffing, IT, and workforce solutions with over 12,000 employees and 70 locations worldwide. As one of the largest IT staffing companies and the 2nd largest minority-owned staffing company in the U.S., Dexian was formed in 2023 through the merger of DISYS and Signature Consultants. Combining the best elements of its core companies, Dexian's platform connects talent, technology, and organizations to produce game-changing results that help everyone achieve their ambitions and goals. Dexian's brands include Dexian DISYS, Dexian Signature Consultants, Dexian Government Solutions, Dexian Talent Development and Dexian IT Solutions. Visit https://dexian.com/ to learn more. Dexian is an Equal Opportunity Employer that recruits and hires qualified candidates without regard to race, religion, sex, sexual orientation, gender identity, age, national origin, ancestry, citizenship, disability, or veteran status