MFG Documentation Associate in Chandler, Arizona at Tailstorm Health Inc

Manufacturing Documentation Specialist

Job Description

Position Summary

The Manufacturing Documentation Specialist is responsible for supporting documentation management, batch record review, SOP coordination, and GMP documentation activities across Medivant Healthcare’s pharmaceutical manufacturing operations. This role plays a key part in ensuring documentation accuracy, regulatory compliance, and operational readiness across manufacturing, quality assurance, and production processes.

The ideal candidate is highly detail-oriented, organized, and comfortable working in a fast-paced regulated manufacturing environment. This position requires strong coordination skills, document control discipline, and the ability to manage multiple priorities while maintaining compliance with cGMP, FDA, and internal quality standards.

Shift Schedule

Monday – Friday
Occasional weekend or extended shift support may be required based on production schedules and operational needs.

Key Responsibilities

Coordinate preparation, review, issuance, reconciliation, and archival of manufacturing batch records and controlled documents.

Support creation, formatting, revision, routing, and approval of SOPs, work instructions, forms, logbooks, and manufacturing documentation.

Ensure manufacturing documentation complies with cGMP, FDA, quality assurance, and internal compliance standards.

Perform routine document review to verify accuracy, completeness, and compliance prior to production release.

Track document revisions, change controls, training records, and document lifecycle activities within document management systems.

Coordinate with Manufacturing, Quality Assurance, Quality Control, Warehouse, and Operations teams to ensure timely documentation support.

Support execution and documentation of deviations, CAPAs, change controls, and non-conformance investigations where required.

Maintain documentation logs, issuance records, archival records, and audit-ready filing systems.

Assist in reviewing manufacturing data, production logs, and operational records for completeness and accuracy.

Support internal audits, external audits, and FDA inspection readiness activities by organizing and retrieving required documentation.

Coordinate training documentation and ensure employees are trained on updated SOPs and manufacturing procedures.

Support continuous improvement initiatives focused on documentation efficiency, compliance accuracy, and process standardization.

Assist with ERP, quality systems, and electronic documentation workflows related to manufacturing operations.

Collaborate with cross-functional teams to improve operational workflows and documentation control processes.

Qualifications

Required:

Bachelor’s degree in Life Sciences, Pharmacy, Chemistry, Biotechnology, Engineering, Business, or a related field.

Minimum 2–4 years of experience in pharmaceutical manufacturing documentation, quality documentation, document control, or regulated manufacturing environments.

Strong understanding of cGMP documentation practices and FDA compliance requirements.

Experience working with SOPs, batch records, controlled documentation, and quality systems.

Strong organizational skills with excellent attention to detail and documentation accuracy.

Ability to manage multiple tasks, prioritize effectively, and meet operational deadlines.

Strong communication and cross-functional coordination skills.

Comfortable working in a fast-paced manufacturing and operational environment.

Preferred:

Experience in pharmaceutical, injectable, sterile manufacturing, or healthcare manufacturing environments.

Exposure to ERP systems, electronic quality management systems (eQMS), or document management platforms.

Familiarity with deviations, CAPA processes, change controls, and audit support activities.

Experience supporting FDA audits or regulatory inspections.

Knowledge of Good Documentation Practices (GDP) and data integrity standards.

Key Competencies

Manufacturing Documentation Management

Batch Record Review & Reconciliation

SOP Coordination & Document Control

cGMP & FDA Compliance

Quality Systems Documentation

Attention to Detail & Accuracy

Cross-Functional Coordination

Audit Readiness & Compliance Support

Operational Workflow Support

Time Management & Multitasking

Process Improvement & Standardization

Data Integrity & Documentation Governance

Please note that we are not providing H1B visa sponsorship for this role. Candidates will be solely responsible for managing and maintaining their own visa sponsorship status.