What are the responsibilities and job description for the Quality Specialist position at TCP Analytical?
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.
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.
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.