Top 22 Quality assurance specialist Jobs in Bethlehem, Pa

Quality Compliance Specialist-Bethlehem, PA
HCSC —Bethlehem, PA
- From $52,300 a year
- Full-time
- Mid-level
- 3 years
- Analysis skills
- Disability insurance
- Health insurance
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5d
Quality Assurance Specialist
Linde —Bethlehem, PA
- Engineering
- Mid-level
- JavaScript
- Paid holidays
- Disability insurance
Senior Quality Assurance Compliance Specialist
Piramal Critical Care, Inc. —Bethlehem, PA
- Full-time
- Microsoft Excel
- Microsoft Outlook
- 5 years
Quality Specialist I
Givaudan —Bethlehem, PA
- $70,000 - $80,000 a year
- 5 years
- Microsoft Office
- Analysis skills
- Health insurance
- Dental insurance
Quality Control Specialist I
OraSure Technologies Inc. —Bethlehem, PA
- $43,000 - $74,000 a year
- Overtime
- Microsoft Excel
- Microsoft Outlook
- Engineering
- Free parking
- Disability insurance
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Quality Audit Specialist
Sharp Clinical Services —Bethlehem, PA
- Full-time
- Customer service
- Mid-level
- 3 years
Field Compliance & Quality Assurance Specialist (Pittsburgh Area)
Miracle Makers Home Care —Pennsylvania
- $15 - $20 an hour
- Full-time
- Background check
- Ability to walk for extended periods
- Mid-level
- Health insurance
- Dental insurance
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4d
Field Compliance & Quality Assurance Specialist (Scranton Area)
Miracle Makers Home Care —Pennsylvania
- $15 - $20 an hour
- Full-time
- Ability to walk for extended periods
- Mid-level
- Office
- Health insurance
- Dental insurance
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4d
Labeling Specialist
Exalta Group —Bethlehem, PA
- Bachelor of Science
- Mid-level
- Bachelor's degree
QC Specialist
Exalta Group —Bethlehem, PA
- Full-time
- OSHA
- Engineering
- Mid-level
Quality Specialist I Logistics
Parexel —Quakertown, PA
- $24 - $33 an hour
- Bachelor's degree
- Continuous improvement
- Organizational skills
- Health savings account
- Health insurance
Senior Quality Audit Specialist
Sharp Clinical Services —Bethlehem, PA
- Full-time
- 7 years
- Mentoring
- Organizational skills
Quality Specialist 2nd Shift
East Penn Manufacturing - Deka Batteries —Lyon Station, PA
- Full-time
- Engineering
- Mid-level
- Analysis skills
- Paid holidays
- Health insurance
Residential Quality Assurance Specialist (IDD)
LifePath —Sellersville, PA
- From $23.10 an hour
- Full-time
- 18 years or older
- Experience working with individuals with developmental disabilities
- Clean driving record
- Paid holidays
- Disability insurance
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Quality Specialist 3/S - Berks County, PA
East Penn Manufacturing - Deka Batteries —Lyon Station, PA
- $31 - $33 an hour
- 8 hour shift
- Engineering
- Mid-level
- Analysis skills
- Paid holidays
- Health insurance
Validation Specialist II
Secant Group —Telford, PA
- Hybrid work
- Computer literacy
- Bachelor of Science
- Engineering
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Quality Compliance Specialist-Bethlehem, PA

HCSC -
Bethlehem, PA

Quick Apply

Job Details

Full-time
From $52,300 a year
5 days ago

Benefits

Disability insurance
Health insurance
Dental insurance
Flexible spending account
Vision insurance
Gym membership
Life insurance
Retirement plan

Qualifications

Driver's License
Bachelor's degree
Quality assurance experience within healthcare

Full Job Description

Are you looking for a job that will have a positive impact in the lives of many people? Do you have a passion to work in a fast-paced, not-for-profit environment? Do you want to support our mission of saving lives? Then, Miller-Keystone Blood Center may be the right fit for you!

At MKBC, we save lives every day by providing blood products to hospitals in PA and NJ. The Quality Compliance Specialist position is responsible for ensuring compliance with regulatory requirements and quality standards within the blood center's Quality Management System. The anticipated annual salary starts at $52,300 and is commensurate with experience. In addition, Miller-Keystone offers the following to all full-time employees:

Medical, Dental, and Vision Benefits
Prescription Plan
Flexible Spending Accounts
Life Insurance
Long Term Disability Insurance
Vacation, Personal and Sick Days
Fitness/Gym reimbursement
Retirement Savings Plan
And Much More!

What you will be doing:

Conduct initial assessments and final quality reviews of CQI deviations, ensuring documentation is complete, accurate, and compliant with internal procedures and applicable regulatory requirements.
Provide support to the Medical Director in completing and reviewing medical and regulatory records, including laboratory reports, donor reentry approvals, medical evaluation forms, special collection documentation, validations, and competency records.
Oversee Component Retrieval activities, including drafting and reviewing hospital correspondence, conducting retrieval reviews, supporting initial hospital notifications as needed, and serving as a backup resource for FDA reporting.
Review and evaluate quality events, including complaints, defective materials, and other quality-related issues, to ensure appropriate documentation, investigation, follow-up, and resolution.
Review donor notification letters for accuracy, consistency, and regulatory compliance, and develop new or revised notifications as needed.
Prepare, compile, and maintain Biologics License Application (BLA) submissions, ensuring submissions are accurate, complete, well-organized, and compliant with FDA regulatory requirements.
Develop, review, and maintain Standard Operating Procedures (SOPs) and related controlled documents within assigned areas of responsibility to ensure alignment with current practices and regulatory requirements.
Support internal and external audits and regulatory inspections by preparing documentation, responding to information requests, coordinating follow-up activities, and assisting with the resolution of audit findings and corrective actions.

What you will bring to the role:

Bachelor's degree in biology, Quality Assurance/Quality Management, Healthcare Administration, Public Health, or a related field is required.
3–5 years of experience required working within Quality Management Systems in a regulated environment, preferably in blood banking, healthcare, clinical laboratory, biologics, or a related industry.
Demonstrated experience with deviation management, CAPA, change control, regulatory compliance, and investigation documentation. Familiarity with FDA regulations and AABB standards and requirements is preferred.
Ability to interpret technical information and communicate complex concepts in clear, user-friendly language.
Excellent written and verbal communication skills, including technical writing, business reporting, and professional presentations.
Ability to understand and follow instructions provided in written, verbal, diagrammatic, and scheduling formats.
Strong analytical and problem-solving skills, with the ability to interpret data and apply sound judgment when making decisions.
Ability to work effectively and collaboratively with a diverse group of employees and cross-functional teams.
Familiarity with Microsoft office suite is preferred.

Additional information:

This position reports to the Senior Director of Quality Assurance and will be based out of our Bethlehem location. They will be responsible for working the following schedule:

The normal hours for this position are 8:30am-5pm.
The expected travel for this position is up to 10%.
Must hold a clear and valid driver's license with reliable transportation.
This position is located in Bethlehem, PA and is fully onsite. Relocation expenses are not covered for this position.

EEO Statement

Miller-Keystone is proud to be an equal opportunity employer and is committed to creating a diverse environment. All qualified applicants are welcomed and will receive consideration for employment without regard to race, color, religion, sex, national origin, age, disability, or any other characteristic protected by law. It shall endeavor to provide reasonable accommodation requested by all employees with documented disabilities who are otherwise able to perform the essential functions of their jobs.

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Refine Your Search

quality assurance specialist jobs in bethlehem, pa

Quality Compliance Specialist-Bethlehem, PA

Quality Assurance Specialist

Senior Quality Assurance Compliance Specialist

Quality Specialist I

Quality Control Specialist I

Quality Audit Specialist

Field Compliance & Quality Assurance Specialist (Pittsburgh Area)

Field Compliance & Quality Assurance Specialist (Scranton Area)

Labeling Specialist

QC Specialist

Quality Specialist I Logistics

Senior Quality Audit Specialist

Quality Specialist 2nd Shift

Residential Quality Assurance Specialist (IDD)

Quality Specialist 3/S - Berks County, PA

Validation Specialist II

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