Quality Assurance (QA) Document Control Specialist - Midatlantic Employers' Association

Lyophilization Technology, Inc. (LTI), established in 1992, is a unique Contract Development and Manufacturing Organization enjoying a leadership position in the health care and related industries. The company conducts applied research, provides scientific services and technical support, and manufactures clinical supplies for freeze dried pharmaceuticals, biologics, diagnostics, biopharmaceuticals and fine chemicals. LTI is located in Ivyland, Bucks County, Pennsylvania.

We have a position opening for Quality Assurance (QA) Document Control Specialist. As a member of the team, the QA Document Control Specialist is responsible for administering Quality Systems knowledge of appropriate scientific and laboratory procedures, methods and techniques, as well as applicable regulations, current Good Manufacturing Practice and customer requirements for the development and manufacture of aseptically produced drug products.

Summary

Provide leadership, management and oversight for electronic Quality Management System (QMS) and Procedural Document Programs which are critical activities for Lyophilization Technology, Inc. (LTI) to ensure the quality of regulatory, current Good Manufacturing Practices (cGMP) operations and documentation compliance, Good Documentation Practices (GDP). Employ industry best practices and management solutions to ensure compliance for documented required procedures. The duties and responsibilities stated below include but are not limited to the following:

Essential Duties and Responsibilities

• Establish/maintain the electronic (QMS) and paper-based Document Control System to process, edit, control and monitor all procedures, instructions and forms to ensure that only current and approved documents are available for use.
• Prepare, issue, scan, and file compliance documentation such as Standard Operating Procedures (SOP’s), Qualification and Validation Protocols, Batch Records, Labels, Logbooks, and Training Records
• Ensure that all proposed changes are reviewed by qualified personnel to assess any impact on other processes or documents, and all are in compliance with cGMP and GDP, domestic and international government regulations and quality standards.
• Coordinate and maintain site training program, training records and training database. Ensure all training is complete and current for any updated procedures.
• Issue periodic notifications, to appropriate responsible departments, and document the process for the timely review of all procedures and other approved documentation.
• Administer/maintain controlled spreadsheets and master lists of documentation.
• Prepare reports for site management on open deviations/CAPA status, open change controls, training status and site quality metrics, as required.
• Assist in regulatory inspections (e.g., FDA, DEA), client audits, internal system audits and minute taking to ensure record and procedural documentation are represented fairly, accurately and are current and available for review.
• Establish and manage the records and retention activities for the Quality Assurance Department and all compliance documentation.
• Management of batch record documentation; Master Batch Record (MBR), MBR issuance for use in production operations, collection, compile, scan and upload completed batch record documentation for client access.
• Maintenance of the ShareFile system: Collect, compile, scan and upload completed documentation for client access.
• Maintain paper and electronic files.
• Provide documentation support to Quality Assurance and LTI personnel.
• Provide administrative support to Quality Assurance.
• Adhere to set safety standards.
• Achieve expected performance measures.

Additional duties as assigned.

Keyword: document control, QMS, quality management systems, cGMP, compliance, audits, regulatory inspections, quality metrics, training
Required Experience:

Qualifications

To perform this job successfully, an individual must be able to perform each essential duty. The requirements listed below are representative of the knowledge, skill, and/or ability required.

• Associates Degree with equivalent in administrative/science related field preferred.
• Minimum 2-3 years relevant work experience in a cGMP environment, and practical administrative experience with emphasis in document processing and control.
• Demonstrated ability to work independently, handle multiple tasks simultaneously, negotiate and meet critical timelines, must have strong attention to detail and strong organizational skills.
• Excellent oral and written communication is required to communicate with the team, peers, management, and external contacts.
• Knowledge with implementing cGMPs, FDA & DEA, US and EU Regulations.
• Proficient working knowledge of personal computers, Microsoft Office products, including but not limited to Excel and Word, document management software, and Adobe Acrobat.
• Proficient with Quality Management Systems (QMS) software, such as ZenQMS is a plus.
• Demonstrated aptitude for learning computer software applications.

Equal Opportunity Employer

We are NOT using search firms to fill this position.

Interested candidates, please submit your résumé along with a cover letter and three (3) professional references via the MEA.jobs website submission. For additional information about Lyophilization Technology, Inc., visit https://www.lyotechnology.com/.

Benefits:

Applying your knowledge and scientific background in a unique technology with an internationally recognized organization, you will receive a competitive salary and comprehensive benefits that include tuition reimbursement, as well as opportunities for professional development and career growth.

Interested candidates, please submit your résumé along with a cover letter and three (3) professional references via the MEA.jobs website submission. For additional information about Lyophilization Technology, Inc., visit https://www.lyotechnology.com/.

From: Midatlantic Employers' Association