Top 13 Quality assurance specialist Jobs in Elyria, Oh

Quality Assurance Specialist (QAS) I
SOFIE —Cleveland, OH
- $33 - $36 an hour
- Mid-level
- Microsoft Office
- 1 year
Quality Assurance Specialist
ImmunoSpot —Cleveland, OH
- Mid-level
- 3 years
- Analysis skills
Quality Assurance Specialist
DSV —Cleveland, OH
- Email
- Computer literacy
- English
- Mid-level
Quality Control Specialist - 1st Shift
Woodbine Products Company —Medina, OH
- $70,000 - $85,000 a year
- Full-time
- Mid-level
- 3 years
- In-person
- Health insurance
- Dental insurance
Quick Apply
Temporary Quality Assurance Specialist
HEALTHPLANONE, LLC —Cleveland, OH
- Full-time
- Spanish
- Microsoft Outlook
- Writing skills
- Health insurance
Quick Apply
FSQA Supplier Quality Specialist
Sandridge Crafted Foods —Medina, OH
- Full-time
- 5 years
- ERP systems
- Mid-level
Quick Apply
8d
YP Live Goods Specialist
GREEN CIRCLE GROWERS INC —Oberlin, OH
- High school diploma or GED
- Math
- Warehouse experience
Quick Apply
10h
QA / QC Specialist - Substation Design
GPD Group —Independence, OH
- Driver's License
- Mentoring
- US work authorization
- Profit sharing
- Disability insurance
Quick Apply
Senior Lead Auditor, Quality Assurance (QA) – Professional Practices & Strategy (PPAS)
KeyBank National Association —Cleveland, OH
- $71,000 - $125,000 a year
- Full-time
- Remote
- CPA
- Writing skills
- Mid-level
Commercial Nuclear Quality Assurance Specialist (Nuclear Software QA)
Johnson Service Group Inc. —United States
- Up to $100 an hour
- Contract
- Remote
- 5 years
- Bachelor of Science
- Writing skills
- Disability insurance
- Health insurance
Quick Apply

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Quality Assurance Specialist (QAS) I
SOFIE —Cleveland, OH
Oversee the examination and evaluation of each lot of incoming material before use to ensure that the material meets its established specifications.
$33 - $36 an hour

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Quality Assurance Specialist (QAS) I

SOFIE
Cleveland, OH

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Job Details

$33 - $36 an hour

Qualifications

Communication with suppliers
Report writing
Presentations for conferences or internal meetings
Technical report writing
Microsoft Office
Manufacturing standard operating procedures
Team training
Vendor communication
Data interpretation
Standard operating procedures (SOPs)
Standard operating procedures drafting

Full Job Description

Description:

Job Description | Quality Assurance Specialist (QAS) I
Title | Quality Assurance Specialist I
Department | Quality/Regulatory/EH&S
Reports To | Regional Manager, Quality Assurance (or equivalent QA Manager)

Compensation | $33-36/hr

Overview

The Quality Assurance Specialist I will be responsible for the oversight of the Quality Assurance program and the Quality Management System at the site level.

Essential Duties and Responsibilities

Maintain oversight of the QA program and Quality Management System (QMS) at a single SOFIE manufacturing facility producing products under both 21 CFR Part 212 and 211 (as needed) regulations.

Apply quality assurance processes and procedures at the site level to ensure product quality and regulatory compliance.

Strong collaboration, including problem solving and continuous improvement efforts, and communication with the Facility Manager and Operations team.

Write, review, approve, and implement procedures, specifications, processes, and methods as required.

Oversee the examination and evaluation of each lot of incoming material before use to ensure that the material meets its established specifications.

Ensure that components, containers, closures, in-process materials, packaging materials, labeling, and finished dosage forms are examined and approved or rejected to ensure that all these meet their current specifications.

Ensure that personnel are properly trained and qualified. Ensure that the training is documented.

Conduct periodic audits of the site to monitor compliance with established procedures and practices. May infrequently audit another site.

Liaise with internal and external inspectors and representatives, particularly on QA-related topics.

Oversee the metrology program at the site (i.e., equipment, personnel qualifications, validations, etc.).

Ensure manufacturing and analytical equipment is appropriately maintained and calibrated. Ensure applicable facility certifications are maintained. Identify to management problems in personnel, equipment, and the facility that require correction.

Review documents associated with the site’s QA program for completeness, errors, and omissions. Review executed CGMP records and product batch records to ensure compliance and product quality.

Review trends (e.g., environmental monitoring, deviations, facility issues, etc.) to initiate corrective and preventive actions and/or for continuous process improvement.
Conduct continuous review of aseptic operations to ensure compliance to internal procedures (e.g., owning, cleaning, sanitation, sterility, environmental monitoring, etc.) and USP/FDA regulations.

Ensure any deviations from normal procedures are documented and justified.

Ensure an investigation is performed and documented when required, and corrective and preventative actions are taken (i.e., follow and maintain corporate CAPA, deviation, and OOS protocols).

Ensure compliance to all applicable standard operating procedures and regulations, including 21 CFR Part 212 (and 211 as needed) requirements.

Ensure product complaints are managed in a manner consistent with Company SOPs and FDA regulations.

Responsible for opening change controls and initiating, maintaining, and reviewing SOFIE network and site-specific procedures relative to their job functions.

Oversee the site-level change control process. Ensure that changes in the laboratory are accepted or rejected as appropriate, and ensure the changes are appropriately documented.

Attend quality and operational meetings. Interface with Corporate QA and Operations on quality related issues. Provide status updates as required management.

Expected extensive knowledge of up to two SOFIE products

Other responsibilities as required.

Qualifications

Bachelor’s Degree (Scientific / Medical / Quality), at minimum, preferred.

Experience and/or full knowledge of manufacturing operations, preparation of sterile injectables, aseptic processing, and distribution of aseptic products preferred.

Quality, Pharmacy, or CGMP manufacturing experience preferred.

Knowledge of USP, FDA, and cGMP regulations preferred.

Knowledge of how and ability to write, review, and revise SOPs required.

Ability to read, analyze, and interpret governmental regulations, general business periodicals, professional journals, or technical procedures required.

Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure

manuals required.

Ability to write reports, business correspondence, and procedure manuals required.

Ability to effectively present information, deliver training, and respond to questions from groups of managers, clients,

customers, and the general public required.

Ability to define problems, collect data, establish facts, and draw valid conclusions required.

Ability to solve problems and handle issues required.

Proficient in MS Office applications required.

Strong interpersonal communication skills for interacting with site personnel, inspectors, and internal and external vendors required.

Requirements for Quality Assurance Specialist (QAS) I

Associate’s or Bachelor’s Degree, at minimum

Relevant certifications and/or experience may be substituted in lieu of this requirement

1-2 years of QA, Pharmacy, and/or CGMP manufacturing experience

Apply Now

Refine Your Search

quality assurance specialist jobs in elyria, oh

Quality Assurance Specialist (QAS) I

Quality Assurance Specialist

Quality Assurance Specialist

Quality Control Specialist - 1st Shift

Temporary Quality Assurance Specialist

FSQA Supplier Quality Specialist

YP Live Goods Specialist

QA / QC Specialist - Substation Design

Senior Lead Auditor, Quality Assurance (QA) – Professional Practices & Strategy (PPAS)

Commercial Nuclear Quality Assurance Specialist (Nuclear Software QA)

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