Quality Specialist

About the CompanyBarker 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 RoleThe 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 SupportSupport maintenance of the Quality Management System (QMS) in compliance with FDA regulations, USP / NF, EP, ISO 9001:2015 or other applicable standardsAssist with document control activities, including issuance, revision, archival, and training coordinationSupport change control, CAPA, deviation, nonconformance, stability and complaint processesBe a backup for creating CofAs and supporting visual inspections of packagingBe a backup for product release including cGMP productsPrepare 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 ReviewReview batch records, QC laboratory records or quality records for completeness, accuracy, and complianceEnsure proper documentation practices are followed (GDP compliance)Assist with data entry and record maintenance in electronic QMS systemsSupport authoring and reviewing validation and qualification documents
Audit & Compliance SupportAssist with internal audits, supplier audits, and regulatory inspectionsSupport preparation of audit materials and follow-up on corrective actionsMaintain audit readiness of quality records and documentation
Continuous ImprovementSupport quality improvement initiatives and metrics trackingParticipate in cross-functional teams to resolve quality issuesSupport 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. xzbcwsv
Required Skills:
Skills and Competencies:Strong attention to detail and organization skillsGood written and verbal communication skillsAbility to follow proceduresFamiliarity with relevant industry standards and regulatory requirements (e.g., FDA, USP, NF, EP).Ability to work collaboratively with cross functional and cross site teamsStrong level of accountability and follow through for execution of project plans
Equal Opportunity StatementTCPA is proud to be an equal opportunity employer.