Quality System Coordinator Position Available In Franklin, Georgia

Quality System Coordinator PTI Georgia LLC 545 Old Elbert Rd, Royston, GA 30662 Maintain multiple (2 or more) Quality Assurance Systems (QASs) such as, but not limited to: Annual Product Reviews (APRs), Audits (internal/external), Corrective and Preventive Actions (CAPAs), Change Controls, Complaints, Deviations, Document Control, Electronic Quality Management System (eQMS), Food Safety, Laboratory Assessments, Releases, Retains, Supplier Corrective Action Reports (SCARs), and Supplier Quality Management, according to all cGMP regulations and PTI procedures/policies, under the direction of Quality Management. Roles are flexible according to requirements and focus areas for Quality Systems.

PRIMARY DUTIES & RESPONSIBILITIES

Manage the daily activities required to maintain assigned QASs pursuant to individual system policies and SOPs. Provide oversight, including guidance and training (as required) to other Quality team members providing QAS support. Perform all activities pursuant to PTI SOPs, cGMP requirements, local and federal regulations (CFRs) and good documentation practices (GDP). Assist in the development of QAS metrics; maintain and report metrics to required stakeholders at defined frequencies. Properly escalate deviations and non-conformances to Quality Management. Provide support on investigations and deviations, as required. Identify and initiate appropriate CAPA, when necessary, and perform follow-up activities. Assist in the development and implementation of process improvements throughout the Quality organization. Assist in the performance of required periodic reviews of Quality SOPs and their revision, as necessary. Effectively communicate via oral and written methods with all departments and employees. Liaison with customers, as needed, while fostering collaborative and positive working relationships. Provide subject matter expert (SME) consult during support of internal, customer, and regulatory audits. Provide additional support for Quality Management as required. Understand drug and food cGMP and company policies. Understand and comply with all site safety practices, as applicable. Proficiency with personal computers/software, including Microsoft Word and Excel. Obtain proficiency with PTI eQMS system use. Working knowledge of pertinent company SOPs, specifications, and batch records. Identify process improvements and propose solutions. Make reasoned, rational decisions to ensure product safety, quality, and efficacy. Perform risk assessments and develop risk management skills. Work independently and autonomously under minimal direction, and as part of a team, as necessary

EDUCATION & EXPERIENCE

Bachelor’s degree or higher in sciences or related field of study. In lieu of a degree, five (5) or more years of direct experience in the pharmaceutical industry.

BASIC SKILLS & PHYSCIAL ABILITIES

Ability to read, write, speak and understand English Ability to perform basic math calculations Ability to communicate well with coworkers and staff to promote professional work environments Ability to work independently or with other team members to accomplish company goals Ability to exercise good judgement, initiative, and organization. Ability to comprehend and accomplish tasks according to guidance and instructions from Management/Supervision Ability to walk and/or stand for extended periods of time Ability to lift or move heavy objects in certain situations Ability to visibly see colors, depths, peripherals, and adjusting focus during various lighting conditions Are you looking to put your writing and critical thinking skills to use in a job that matters? APPLY for this JOB and come be a part of delivering on promises and making the world a better place. Pharma Tech Industries, a leading CDMO specializing in pharmaceutical packaging, is seeking a dynamic Quality Systems Coordinator. This role will support our operations by ensuring we are compliant with the FDA and other quality system regulatory bodies. The role requires someone with attention to detail, impeccable writing skills, and critical thinking.