Back to Jobs search

QA Documentation Assistant (Release)

Belcan • Myerstown, PA • 3h ago

Job Number: 361931

Category: Administrative

Description: Job Title: QA Documentation Assistant (Release)

Location: Myerstown, PA

Zip Code: 17067

Keyword's: #Myerstownjobs; #QADocumentationAssistantjobs;

Start Date: Immediate

Local candidates ONLY

Main Purpose

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.

Key Tasks & Responsibilities

May include, but not limited to, the following:

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

Key Working Relationships

Works closely with one or more of the following: Supplier Quality Assurance manufacturing sites and Morristown, Supply Chain, Production Departments, Warehouse, and QA personnel. For QA Doc release area, would also interact often with QA in Alcala and Bitterfeld, as well as management at Myerstown site management; has broad impact across the site from normal batch record process to working with PrT to issue documents, qualification reports, and testing documents.

Requires good interpersonal and oral communication skills.

May have to handle potentially sensitive matters related to inspection and /or auditing problems.

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.

Belcan is an equal opportunity employer. Your application and candidacy will not be considered based on race, colour, sex, religion, creed, sexual orientation, gender identity, national origin, disability, genetic information, pregnancy, veteran status or any other characteristic protected by federal, state or local laws.

Location: Myerstown , PA

Minimum Experience (yrs): 5

Required Education: High School Diploma

Benefits:

Return to search results Email this job to a friend (emailjobs.asp?jo_num=361931)

If you have previously registered with us, pleaseLog in (memberlogin.asp) to apply for this position.

*Logged in members may also add jobs to their job cart

Belcan

Go to Apply

Share this job

Similar Jobs

Cashier-Part Time

Cabela's • Hamburg, PA • 11min ago

Retail & Hospitality

POSITION SUMMARY: The Cashier is responsible for checking out customer's merchandise through the POS registers. They perform various Customer Service activities, to include greeting and acknowledging all customers in a p...

11min ago

Go to Apply

Cashier-Part Time

Cabela's • Hamburg, PA • 11min ago

Retail & Hospitality

11min ago

Go to Apply

Assembler

SECHAN ELECTRONICS INC • Lititz, PA • 1h ago

Manufacturing & Warehouse

Reference #: FAS0318 The Final Assembler builds final product to print by placing all necessary wiring, wiring harnesses, circuit cards and other hardware components within a chassis. Position Responsibilities: Manually...

1h ago

Go to Apply

Warehouse Svc Specialist (B) - 1st Shift

Parker - Mitos • Lancaster, PA • 2h ago

Manufacturing & Warehouse

Reference #: 16955689 Job Description Apply Now > Save Job Job Saved At Parker Hannifin's Hydraulic & Aerospace Filtration Division (HAFD), we specialize in manufacturing high-quality products that filter, purify,...

2h ago

Go to Apply

Crane Mechanic

Aerotek • Manheim, PA • 2h ago

Manufacturing & Warehouse

Job Title: Crane Mechanic Join our team as a Crane Mechanic, where you will be responsible for building, maintaining, and performing preventative maintenance on cranes. You will have the opportunity to work with a variet...

2h ago

Go to Apply

CB Portfolio Specialist

First Commonwealth Bank • Lancaster, PA • 2h ago

Assists Corporate Bankers and Portfolio Managers in managing existing Corporate Banking relationships. Acts as a contact person when the Corporate Banker and/or Portfolio Manager are not immediately available and provide...

2h ago

Go to Apply

MIG Welder

Aerotek • Denver, PA • 2h ago

Manufacturing & Warehouse

Job Title: MIG Welder Essential Skills At least 2 or more years of custom environment welding experience. Proficiency in thin gauge metal fabricating. Ability to read blueprints. Experience with MIG welding, press operat...

2h ago

Go to Apply

Patient Care Equipment Service Processor (Full-Time, Night Shift)

Penn Medicine • Lancaster, PA • 2h ago

Hospital & Medical

Description Penn Medicine is dedicated to our tripartite mission of providing the highest level of care to patients, conducting innovative research, and educating future leaders in the field of medicine. Working for this...

2h ago

Go to Apply

Retail Assistant Store Manager

Russell Stover Candies • Hamburg, PA • 3h ago

Retail & Hospitality

My Account Job Openings >> Retail Assistant Store Manager Retail Assistant Store Manager SummaryTitle:Retail Assistant Store Manager ID:201400 Department:Retail Location:Hamburg, PA (Retail Store #466) Classificati...

3h ago

Go to Apply

Senior Materials Development Engineer

Leviton • New Holland, PA • 3h ago

IT & Engineering

About Leviton At Leviton, we build what's next to light, power, and connect everyday spaces, from electrical to lighting, to data networks, and energy management. With over 115 years of history, Leviton develops thoughtf...

3h ago

Go to Apply

Subscribe to get new jobs sent directly to you
(no charge, cancel anytime)

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.