Quality Assurance Assistant

Position Details:

Job Title: Quality Assurance Assistant

Duration : 6 + Months

Location : Myerstown, PA
Pay rate : $25-30/hr

Job Summary:

In this role, you will be responsible for ensuring that packaging components and intermediates conform to current good manufacturing practices (cGMPs), standard operating procedures (SOPs), and plant quality standards. You will review in-process records and quality assurance test results, assign dispositions, and maintain essential databases while collaborating with various departments to uphold the highest quality standards.

Responsibilities:

– Coordinate priorities with QA or SQA staff to ensure timely completion of top priority work.

– Review test results and documentation for packaging components; accept/reject based on usage decisions.

– Initiate and maintain communication with suppliers regarding new and revised specifications.

– Prepare and maintain databases such as Approved Supplier Database, CofC Database, and others.

– Support investigations by reviewing batch manufacturing and packaging records for accuracy.

– Maintain records associated with complaint samples, including log books and labels.

– Write and update/revise SOPs relevant to the area of focus.

– Prepare internal Quality Principle Audit schedules and manage CAPA entries.

– Perform audits in production areas according to internal Quality Principle Audits.

– Audit manufacturing and packaging documentation for GMP compliance if assigned to QA Doc Release.

– Review production records for accuracy; perform mathematical audits of calculations.

– Issue/Reconcile manufacturing, packaging, and QC laboratory documents according to SOPs.

– Support document control practices in the issuance/reconciliation of working documents.

– File labeling exhibits, specification sheets, expiration authorizations, and storage documentation appropriately.

– Coordinate testing/release of work in process with production, QA, and SCM departments.

– Maintain batch manufacturing record files according to storage procedures.

Skills:

– Strong interpersonal skills with effective oral communication abilities.

– Excellent written communication skills.

– Demonstrated leadership skills in auditing cGMP documentation.

– Strong organizational skills with attention to detail.

– Ability to interpret records accurately with good mathematical calculation skills.

– Legible handwriting is required.

– Physically able to lift up to 50 pounds.

Qualifications:

– High School degree or GED with at least 5 years of experience in a document review/auditing role within a cGMP industry is required.

– College background or secretarial/administrative certifications are a plus.

– Previous experience using SAP, MES, or other automated inventory systems is required.

– Proficiency in MS software is preferred.

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.