Top 6 Quality assurance specialist Jobs in Boulder County Co

Senior Quality Assurance Specialist I
Cambrex —Longmont, CO
- Full-time
- Computer literacy
- Bachelor of Science
- Writing skills
QA Product Specialist
Corden Pharma Colorado —Boulder, CO
- $100,000 - $118,000 a year
- Full-time
- Ability to walk for extended periods
- 5 years
- Mid-level
- Wellness program
- Paid parental leave
Quick Apply
Compliance Specialist Senior – Quality Management System Auditor
BAE Systems Inc. —Broomfield, CO
- $82,779 - $140,723 a year
- Full-time
- Hybrid work
- Bachelor of Science
- Master's degree
- Analysis skills
- Health savings account
- Paid holidays
Sr. Supplier Quality Management Specialist
Corden Pharma Colorado —Boulder, CO
- $115,000 - $125,000 a year
- Full-time
- Word processing
- Bachelor of Science
- 11+ years
- Wellness program
- Paid parental leave
Quick Apply
Quality Specialist II
Rfi Llc —Broomfield, CO
- $50,000 - $65,000 a year
- Full-time
- Spanish
- English
- Mid-level
- Disability insurance
- Health insurance
Quick Apply
Data Operations Specialist – Head Start (Data Quality, Records & Governance)
JBS International —Denver, CO
- Mid-level
- 3 years
- Ability to lift 50 pounds
Quick Apply

Explore jobs in cities nearby

Check out jobs in cities near your current location, Columbus

Quality Assurance Specialist
Accel Inc —New Albany, OH
Assist with non-conformance assessments, findings, reports, CAPAs, and root cause analysis. Accel is hiring a *Quality Assurance Specialist* to perform routine…
$19 an hour
Quick Apply
Quality Assurance Specialist (QAS)
Fox River Associates —Columbus, OH
Auditor certification by accredited body (Certified Quality Engineer/Certified Quality Technician/ISO 9001:2015 Lead Auditor Training).
$60,000 - $65,000 a year
Quick Apply

I want to receive the latest job alert for quality assurance specialist in boulder county co

By signing in to your account, you agree to SimplyHired's Terms of Service and consent to our Cookie and Privacy Policy.

Explore jobs in more locations

quality assurance specialist jobs near boulder county co

Data Specialist jobs in Denver, CO

Quality Assurance Specialist jobs in Boulder, CO

Senior Quality Specialist jobs in Boston, MA

Senior Quality Specialist jobs in New Brunswick, NJ

Senior Finance Manager jobs in Atlanta, GA

Senior Quality Specialist jobs in Phoenix, AZ

Discovery Senior Living jobs in Florida

Senior Quality Specialist jobs in Chicago, IL

Remote Senior jobs in Columbus, OH

Customer Success Specialist jobs in Chicago, IL

Data Entry jobs in Sioux Falls, SD

It Support Specialist jobs in Seattle, WA

Data Specialist jobs in Bellevue, WA

Data Specialist jobs in Baton Rouge, LA

Data Specialist jobs in Washington, DC

Data Specialist jobs in Pasadena, CA

Food Quality Assurance jobs in Buffalo, NY

Quality Assurance Specialist jobs in Elk Grove Village, IL

Remote Onboarding Specialist jobs in Texas

Quality Assurance Specialist jobs in Honolulu, HI

Senior Quality Assurance Specialist I

Cambrex -
Longmont, CO

Apply Now

Job Details

Full-time

Qualifications

Customer communication
Bachelor's degree

Full Job Description

Overview:

The Senior Quality Assurance Specialist I is an expert in their assigned area and has a strong understanding of current FDA, EU and ICH requirements. This role may specialize in various aspects of technical data and documentation evaluation and review, manufacturing operations, laboratory operations, investigations, and a variety of routine and non-routine tasks. This role ensures that all QA activities are in compliance with company SOPs, GMP/GLP standards and client requirements.

This role will coordinate with appropriate departments and/or cross-functional teams to ensure all applicable documents are reviewed and released within the specified timeframes. Ability to work within a dynamic and fast paced environment.

Responsibilities:

Responsible for performing an independent quality evaluation and release of support documentation, materials, products, equipment, and facilities.
Ensure all testing/manufacturing was performed per approved SOPs/methods/protocols and comply with specifications by critically evaluating the reported data and results for accuracy and compliance with other regulatory guidelines.
Works independently on problems of basic to moderately complex scope in which analysis of situation or data requires a review of identifiable factors.
Participates in department/client meetings, collaborates, and cooperates to achieve cross-functional improvements and business goals.
Foster a culture of quality and continuous improvement focused on value to the customer.
Ability to host and/or participate in internal, client and/or regulatory audits. Works with the site management in all areas to maintain a cGMP compliant facility in a constant state of inspection readiness.
Exercises judgment within defined procedures and practices to determine appropriate action (root cause analysis tools, CAPA, etc.) for quality events.
Good interpersonal skills and willing to ask questions about procedures and concepts.
Participates in the development, implementation, and maintenance of procedures and policies to comply with FDA, EU, and ICH requirements applicable to site’s needs.
Able to be trained and train/ mentor others.
Effectively resolves quality issues and concerns in a timely manner.
Effectively coordinates and organizes tasks to help drive the activities of others; while performing a variety of duties on schedule, with accuracy and competency.
Creates strong and effective working relationships with Quality team, colleagues, and clients.

Qualifications / Skills::

Knowledge

Strong attention to detail, as well as time and resource management.
Strong personnel and professional integrity and trustworthiness with strong work ethics and the ability to independently with minimal direction.
Promote a safe environment for work.
Communicate clearly and effectively both orally and in writing with internal and external clients.
Working knowledge and understanding of LIMS and Empower.
Skilled in MasterControl, Trackwise and/or other QMS software applications.
Understanding of validation, production equipment, utilities, and/or drug development/manufacturing operations.
Demonstrated theoretical understanding and providing effective evaluation of laboratory practices such as raw material, drug substance, drug product and medical device testing, compendia methods (e.g. USP/NF, EP, JP), and method validation/qualification/transfer, as required.

Skills / Abilities:

Demonstrate the capability for continued upward growth and technical contributions.
Strong analytical and problem-solving skills with proven ability to think strategically.
Strong understanding of current FDA, EU and ICH requirements and implementation for GLP and GMP in the pharmaceutical industry
Effective team and interpersonal skills with the ability to work across numerous scientific and management disciplines.
Excellent diplomatic, analytical, and communication skills – both verbal and written.
Recognized as a technical resource in their assigned area.
Strong Computer Skills
Microsoft Suite, proficiency

Qualifications:

Related BA/BS, required.
4 -6 years of relevant experience in a CDMO and/or pharmaceutical environment, preferably in Quality Assurance.
Experience in manufacturing operations, laboratory operations and/or QA, preferably in pharma or biotech.

Apply Now

Refine Your Search

quality assurance specialist jobs in boulder county co

Senior Quality Assurance Specialist I

QA Product Specialist

Compliance Specialist Senior – Quality Management System Auditor

Sr. Supplier Quality Management Specialist

Quality Specialist II

Data Operations Specialist – Head Start (Data Quality, Records & Governance)

Explore jobs in cities nearby

I want to receive the latest job alert for quality assurance specialist in boulder county co

Explore jobs in more locations

Job Seeker Tools

Employer Tools

Browse

Stay Connected