The Quality Assurance Documentation Specialist will report to the Supervisor, Quality Assurance and will be performing a wide variety of activities pertaining to assuring quality and compliance in adherence to applicable Regulatory requirements and company’s quality policies.

Activities include but are not limited to review of GMP data for compliance, review of GMP documentation to support batch disposition, review/approval of GMP procedures, protocols and reports. The Quality Assurance Documentation Specialist position will maintain the Quality Standards of the company’s products or services by ensuring adherence to company SOPs, Regulatory guidance and client specific requirements.

Assist in all aspects of Quality in respect to submission batches and commercial products as required. This position provides Quality Assurance support to the Development, Operations, Quality Engineering/Quality Control, and Regulatory Affairs departments.

Document Specialist will closely work with Head of Quality Assurance to maintain Quality Management System includes Documentation Control, Change Control, Investigation and CAPA Management, Training, Internal/External Audits, Customer Correspondence, Vendor Qualification, Cleaning and Process Validation. The Documentation Specialist will work with department authors to edit, format, illustrate, update, and create new standard operating procedures and other related documentation such as master batch records, logbooks, and other technical documentation in support of cGMP.

The Documentation Specialist will support internal and external audits and inspections and support the Quality Review Board and Management Review process. Primary responsibilities include, but are not limited to, the following:

• Coordinates the revision process of controlled documentation.

• Assists in organizing QA records and scanning, archiving, maintain historical files for controlled documentation.

• Enters, updates, and edits-controlled documents and coordinate requirements for new documents with internal departments and customers.

• Controls and issues logbooks and review executed logbooks and archive.

• Controls and issues batch production records and QC testing results in support of manufacturing.

• Finalize and issuance of working documents like SOPs, batch records etc. for use by Production and test methods and validation protocols etc.

• Control distribution and monitor workflow of controlled documents maintain document database on Revised and distributed SOPs.

• Perform review and approval of batch related documentation (cGMP procedures, Manufacturing batch records, QC testing CoAs, protocols and reports, etc.) to support product disposition.

• Issue controlled documents for training, testing or batch production purposes.

• Assist in writing SOPs, reports and protocols, Vendor Qualification, Quality Agreement as needed.

• Support implementation of Quality System Improvements with Management’s guidance in moderate technical problem solving within function and/or cross-functional areas.

• Support site training initiatives by participating in New Employee orientation activities, including training employees on general cGMP requirements, coordinating training of site employees as required.

• Participate in Regulatory inspection and internal audit, as required.

• Perform duties regarding special projects, as assigned by QA Management.

Primary skills and knowledge required include, but are not limited to the following:

• Intermediate knowledge of document management principles. Experienced in writing GMP standard operating procedures which adhere to regulatory requirements.

• Proficient in Paper based Document Management systems and document formatting/word processing

• Demonstrated ability in performing document coordination and archival activities

• Demonstrated ability in managing tracking databases and logs

• Strong internal customer service/people skills are required

• Ability to present self in a professional, credible manner and communicate effectively at all levels of the organization

• Positive attitude, self-motivated, strong work ethic, organizational skills, communication skills, critical thinking, attention to detail and accuracy, the ability to work independently and in a team environment, are essential.

• Excellent professional verbal, written, and communication skills.

• Capable of timely completing assigned responsibilities under supervision where required and keeping superior informed of status.

• Ability to prioritize and organize own work, multi-task, meet deadlines and keep commitments.

• Flexible and able to respond quickly to shifting priorities and meet deadlines.

• Works under supervision where required and follows established procedures along with own judgment.

• Capable of developing innovative/creative solutions to issues of normal

• Proficiency with Microsoft Office tools and other office (Excel, Word, PowerPoint, Outlook). Level of Education Required/Preferred Field of Study:

Education and Experience in the Function and in the Industry:

• 3+ years of demonstrated practical Quality Systems or Quality Documentation Control or Quality Assurance experience directly related to position responsibilities.

• Certificate or Associates Degree in science OR an equivalent combination of education and experience in related field of pharmaceutical or biopharmaceutical industry.

• General understanding and knowledge of relevant US FDA regulations.

• General understanding of Quality concepts/requirements and be able to practice and implement them.

• General understanding of GMP manufacturing processes drug products preferably oral solid dosage.

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Quality Assurance Associate