Apozeal Pharma is a leading manufacturer and supplier of generic pharmaceutical formulations. The Document Control Associate will assist with the day-to-day document control activities within the Quality Assurance department as well as other key departments to ensure that all GMP documents are filed systematically and easily retrievable. The Document Control Associate is responsible for control of documents associated with the manufacture and testing of products in accordance with company SOPs, policies, and GMPs. This is an hourly, non-exempt position. Employees may be required to work overtime to meet production needs.

Major Tasks, Key Responsibilities and Key Accountabilities:

• Maintain a document control management system compliant with regulatory, quality and company policies and requirements.
• Maintain GMP audit files and assist with entry, tracking, and archiving of audit records.
• Involved in controlled documents lifecycle and periodic review management.
• Perform review of documents submitted through the change control process for format and style, completeness, and review and approvals.
• Process document requests to be used in-house or sent to Contract Service Providers in a timely manner.
• Help in preparation and manage the revision, distribution, and maintenance of controlled documents including Standard Operating Procedures, specifications, protocols, and other miscellaneous documents.
• Maintain controlled document libraries, assuring the areas are organized, orderly, and clean.
• Issue working and reference copies of controlled documents to site staff.
• Prepare controlled documents through the change control process including editing, proofreading, tracking, copying, distributing, scanning, and filing.
• Audit controlled document files in preparation for regulatory inspections and client audits.
• Provide support for regulatory inspections and client audits.
• Ensure all work is performed and documented in accordance with GMP requirements and existing company policies and procedures.
• Assist staff regarding document control processes.

Basic Qualifications:

• A minimum of a BS in Pharmacy, Chemistry or related science.
• 2-5 years’ experience in pharmaceutical Quality Assurance.
• Proficient knowledge of a GMP production facility, manufacturing processes, and/or inspection processes.
• Computer literacy in Windows applications and the MS Office (Word, Excel, Outlook) package.
• Must pass drug test and background check.

Preferred Qualifications:

• Ability and willingness to work flexible hours.
• Great attention to detail, quality and a desire for success.
• Ability to organize and adapt to organization priority changes and work effectively with minimal supervision / independently with a sense of urgency.
• Ability to work on multiple projects
• Ability to multi-task effectively.
• Self motivated individual with the attitude and ability to be successful on the QA Team.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, or national origin.