QA Associate

Actalent; United States; On-site; USD 55,000 - 80,000; Full time

Job summary

Actalent in the United States seeks a QA Associate to support data review, batch record management, and quality documentation for animal health and nutrition products. You will collaborate with production, QC labs, supply chain, and customer service to ensure cGMP compliance, maintain SOPs, and support continuous improvement in a highly regulated environment.

This role emphasizes attention to detail, strong communication, and proficiency with electronic systems such as Veeva Vault to document

Qualifications

• Bachelor's or Associate's degree in a related field, or at least 12 months QA or GMP experience.
• GMP, pharmaceutical, life science, or highly regulated quality environment experience.
• Strong communication with QC, Supply Chain, Customer Service and stakeholders.
• Strong documentation skills, SOP review, and quality documentation management.
• Proficiency with electronic document systems such as Veeva Vault.
• High attention to detail in a regulated environment.
• Experience with batch record review and maintenance.

Responsibilities

• Support quality systems by organizing, critically reviewing, and presenting information per procedures and cGMP.
• Provide day-to-day quality support for production areas to ensure compliant operations.
• Apply statistical analysis to support quality decisions and data evaluation.
• Write, review, and revise GMP SOPs to maintain compliant documentation.
• Track, maintain, review, and correct manufacturing records (tickets) for disposition.
• Communicate with QC laboratory about test results for batch release.
• Coordinate with Supply Chain to ensure timely release of batch records.
• Approve raw materials by evaluating COAs, printing permits, and tracking vendor information.
• Coordinate with material coordinators on materials received and needed.
• Print and prepare batch manufacturing records and labels.
• Create COAs and AQIS documents, updating certifications and permits as needed.
• Track COA requests and ensure timely delivery of analyses.
• Perform inbound quality analysis and approve packaging materials.
• Monitor temperature records for bulk materials to ensure proper handling.
• Approve bulk material received for companion animal products.
• Manage documents in Veeva Vault for QA/TS-MS review and approval.
• Ensure quality documentation, SOPs, and batch records are accurate and maintained.
• Conduct QA checks and tests such as titration and pH where applicable.
• Identify process/documentation improvements and support optimization efforts.

Skills

Strong communication

Strong documentation

Math skills

Veeva Vault

GMP experience

Education

Bachelor's or Associate's degree

Tools

Veeva Vault

Job description

Job Description

Job Description

Job Title: QA Associate

Job Description

The QA Associate supports the review and analysis of data related to product and packaging quality, ensuring compliance with cGMP standards, written procedures, and applicable regulations. This role provides quality systems support, partners closely with production, supply chain, QC laboratories, and customer service, and plays a key role in batch record management, material approval, and quality documentation for animal health and nutrition products.

Responsibilities

• Support quality systems by organizing, critically reviewing, and presenting information in accordance with written procedures and cGMP standards.


• Provide day-to-day quality support for production areas to help ensure compliant manufacturing operations.


• Apply or obtain statistical analysis to support quality-related decisions and data evaluation.


• Write, review, and revise GMP standard operating procedures to maintain accurate and compliant documentation.


• Track, maintain, critically review, and correct manufacturing records (tickets), and print additional documentation to include with manufacturing records for disposition.


• Maintain communication with the QC laboratory regarding test results that are pertinent to batch release, ensuring timely and accurate information flow.


• Maintain communication with Supply Chain representatives to ensure batch manufacturing records are released in a timely manner.


• Approve raw materials for use in production areas by evaluating vendor Certificates of Analysis (COAs), printing permits, approving materials as they arrive on site, blocking and unblocking material as needed, and tracking vendor information on a shared site for visibility.


• Maintain communication with material coordinators to ensure awareness of materials received on site and materials urgently needed in production areas.


• Print and prepare batch manufacturing records as requested by Supply Chain, including manually printing product shipping labels, verifying count and variable data information, tracking and creating additional labels as needed, and coordinating timely pick up and drop off of records and labels.


• Create or prepare Certificates of Analysis (COAs) as requested by Customer Service representatives, including creation of AQIS documents and permits, updating health and non-radiation certifications, and creating Certificates of Manufacturing and Certificates of Conformity.


• Track COA requests, create irregular COAs and COA templates, and mail documents to Customer Service representatives while maintaining communication to ensure timely delivery of Certificates of Analysis to the destination country.


• Perform inbound quality analysis and receipt for printed packaging materials, and approve printed packaging materials for use in production areas.


• Monitor temperature records of bulk material received for companion animal products to ensure proper storage and handling.


• Approve bulk material received for companion animal products based on quality and compliance criteria.


• Own, track, and route documents in Veeva Vault for edit, review, and approval as needed for Quality Assurance and Technical Service/Manufacturing Science representatives.


• Ensure quality documentation, including SOPs, batch records, and certificates, is accurate, complete, and maintained in a highly regulated environment.


• Conduct QA checks and QA tests as needed, supporting laboratory and analytical activities such as titration and pH testing, where applicable.


• Contribute to continuous improvement of quality processes by identifying documentation or workflow issues and collaborating on solutions.

Essential Skills

• Bachelor's or Associate's degree in a related field, or no degree with at least 12 months of QA or GMP experience.


• Demonstrated experience working in a GMP, pharmaceutical, life science, or highly regulated quality environment.


• Strong communication skills, with the ability to maintain clear, timely communication with QC, Supply Chain, Customer Service, and other stakeholders.


• Strong documentation skills, including accurate recordkeeping, SOP review, and quality documentation management.


• Solid math skills to support data analysis, statistical evaluation, and verification of counts and variable data.


• Proficiency with computers, including working with electronic document systems such as Veeva Vault and shared sites.


• High attention to detail and the ability to work effectively in a highly regulated environment with strict procedures.


• Experience with batch record review and batch record maintenance.


• Knowledge of cGMP principle