QA Document Control Associate

Pine Pharmaceuticals; City of Tonawanda, Northern (NY, KY); On-site; USD 55,000 - 75,000; Full time

Job summary

Pine Pharmaceuticals is seeking a QA Document Control Associate in New York to support QA activities and maintain the Central File system. You will issue controlled documents, review batch records, and assist in MasterControl tasks while ensuring compliance with GMP and 21 CFR 210/211.

The role requires a high school diploma or higher with 1+ year in a regulated environment; proficiency in Excel and Word is essential, and experience with electronic QMS is preferred.

Qualifications

• Must have GMP knowledge and experience with controlled document filing.
• Experience in electronic Quality Management Systems is preferred.
• Proficient with Microsoft Office (Excel/Word) and document scanning.

Responsibilities

• Create and issue controlled documents (batch records, specifications, logbooks).
• Review batch production records for accuracy and completeness to ensure timely release.
• Confirm disposition of batch-associated nonconformances prior to release.
• Route documents for corrections and corrections follow-up.
• Use ERP to manage batch dispositions and distribution readiness.
• Support MasterControl document archival and collaborations.
• Maintain Central File system and readiness for audits.
• Assist QA activities and continuous improvement initiatives.

Skills

GMP knowledge

Document control

Attention to detail

Excellent communication

Independent work

Team collaboration

Education

High School diploma or equivalent

Associate/Bachelor in Science/Life Sciences preferred

Tools

Excel

Word

MasterControl

Job description

Position Summary:

As the QA Document Control Associate, you will support Quality Assurance (QA) activities. Activities include but are not limited to: Maintenance and organization of the Central File system, Issuance of documents, Review and Release of Batch Records, and Support of MasterControl tasks (such as Document Collaborations). All in accordance with current Good Manufacturing Practices and 21 CFR 210/211.

Essential Functions:

• Generation and Issuance of controlled documents, including but not limited to Batch Record documents/forms, specification, and logbooks.
• Review of lot specific documentation for Batch Production Records (including raw data, batch record associated pages, release specifications, and test results) to confirm accuracy, completeness, and compliance to ensure prompt batch disposition and release.
• Confirm disposition of batch-associated nonconformances and quality events prior to batch release.
• Identification and routing of documents (both paper and electronic) for corrections in cases of missing or incorrect documentation.
• Work with company personnel to correct any mistakes identified during review.
• Use ERP system to select the proper disposition of individual batches and notification of availability for distribution.
• Generation of controlled labels utilized throughout the manufacturing and packaging process.
• Review of logbooks, as needed.
• Maintain and control the Central File system utilized for the storage of all paper-based documents needed for retention.
• Maintain department for readiness for internal and external audits.
• Retrieval of documents from filing systems during times of internal or external audits.
• Control of department inventory needs, regarding supplies needed for batch record and document issuance, and the central filing system.
• Support Document Collaboration and Set Dates for all document creation/revisions.
• Support the maintenance and control of electronic document archival within the MasterControl Software.
• Build and maintain collaborative working relationships within the organization.
• Effective communication throughout all facets of the organization.
• Follow and solicit good manufacturing and documentation practices.
• Support QA activities as needed.
• Support Quality management System continual improvement initiatives.
• Triage workflow to ensure first in-first out or priority release of finished product or product dependent documents according to distribution needs.
• Other activities/tasks as dictated by departmental and organizational needs.

Education and Experience:

• A High School diploma or equivalent and a minimum1 year experience in a regulated environment, Pharma or other medical preferred.
• Or an Associate degree or Bachelor degree in Science/Life Sciences preferred.
• Must be proficient with computers. Knowledgeable with standard Microsoft Office suite, email, document scanning, and strong Excel and Word experience.

Knowledge, Skills, and Abilities:

• Knowledge of GMP’s.
• Knowledge & experience with organization and filing of controlled documents.
• Knowledge & experience with use of electronic Quality Management Systems.
• Excellent interpersonal communication skills.
• Must be able to work independently and as part of a team.
• Must have attention to detail.
• Self-motivated and organized.