About this opportunity
TCP Analytical lists this Quality Specialist opportunity in charlotte, North Carolina. Review the employer’s description below for duties, qualifications and application requirements.
Job description
About the Company
Barker Industries, a TCP Analytical company, is a manufacturer of High Purity Chemicals for the pharmaceutical, electronic, aerospace and research and development industries.
A variety of soft skills and experience may be required for the following role Please ensure you check the overview below carefully.
About the Role
The Quality Specialist supports the Quality Management System (QMS) to ensure compliance with applicable regulatory requirements, company procedures, and quality standards. This role assists with documentation control, product release, record review, audits, CAPA activities, QC support and day-to-day quality operations in a regulated manufacturing or laboratory environment.
Responsibilities:
Quality System Support
Support maintenance of the Quality Management System (QMS) in compliance with FDA regulations, USP / NF, EP, ISO 9001:2015 or other applicable standards
Assist with document control activities, including issuance, revision, archival, and training coordination
Support change control, CAPA, deviation, nonconformance, stability and complaint processes
Be a backup for creating CofAs and supporting visual inspections of packaging
Be a backup for product release including cGMP products
Prepare regulatory documents as needed, such as BSE-TSE-GMO statements and country of origin statements.
Participate in team meetings, attend required training, and support quality and business goals and initiatives.
Documentation & Record Review
Review batch records, QC laboratory records or quality records for completeness, accuracy, and compliance
Ensure proper documentation practices are followed (GDP compliance)
Assist with data entry and record maintenance in electronic QMS systems
Support authoring and reviewing validation and qualification documents
Audit & Compliance Support
Assist with internal audits, supplier audits, and regulatory inspections
Support preparation of audit materials and follow-up on corrective actions
Maintain audit readiness of quality records and documentation
Continuous Improvement
Support quality improvement initiatives and metrics tracking
Participate in cross-functional teams to resolve quality issues
Support quality projects such as eQMS module implementation, label program implementation, or any other projects as required
Qualifications:
Education:
Bachelor’s degree in Chemistry or science related field.
Experience:
3+ years of experience in quality role.
Experience in a regulated industry (e.g., manufacturing, pharmaceuticals, healthcare).
Certifications (preferred):
ISO 9001 training or similar quality-related certifications. xqrzhdi
Required Skills:
Skills and Competencies:
Strong attention to detail and organization skills
Good written and verbal communication skills
Ability to follow procedures
Familiarity with relevant industry standards and regulatory requirements (e.g., FDA, USP, NF, EP).
Ability to work collaboratively with cross functional and cross site teams
Strong level of accountability and follow through for execution of project plans
Equal Opportunity Statement
TCPA is proud to be an equal opportunity employer.
Worksite address
charlotte, NC, 28269, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.