ASSOCIATE QUALITY ASSURANCE
REGULATORY AFFAIRS, Boothwyn, PA

🌟 Come Join Our Team! 🌟

To support our continued growth, Globyz is recruiting an Associate Quality Assurance & Regulatory Affairs professional.

Position: Associate Quality Assurance & Regulatory Affairs
Locations:

• Boothwyn, PA, USA

Position Description
To perform the Quality Assurance & Regulatory duties for the drug products distributed by Globyz Pharma. Reporting to Vice President of Quality and Regulatory Affairs, you will be responsible for performing the day-to-day activities for the inspection and release of drug products and Controlled drug products received at Globyz Pharma. You will ensure that SOP procedures are implemented and followed at Globyz Pharma for the product receipt, storage, inspection, and shipping. Review the data and ensure that product storage environments are controlled and maintained for the storage of drug products as per the manufacturer’s instructions at Globyz facility. The focus will be to ensure that documentation for the Quality systems (Deviation, Change Controls, Customer Complaints), SOP revision, and training are completed in a timely fashion as per Globyz policies and meet regulatory requirements.

Responsibilities

• Perform the day-to-day activities of the quality department.
• Perform Quality Inspection and release of received goods (products, Packaging materials) and complete GMP documents in a timely fashion.
• Perform Daily Temperature Monitoring of product storage areas at Globyz Pharma and report any excursions/alarms to management and initiate investigation as per Globyz’ policies.
• Print the weekly summary of Temperature data from the electronic system and review, sign, and file accordingly.
• Maintain the original approved SOP binder at Globyz Pharma and initiate the SOP review on or before its next due date as per Globyz Pharma policies.
• Maintain the training records of the entire GMP staff. When applicable, initiate the training of new and/or revised SOP.
• Participate in the Quality systems; deviation, change controls, and customer complaints processes. Participate in investigation and complete reports in a timely fashion.
• Participate in the self-inspection program and document the observations and follow up on CAPA.
• Perform periodic review of completed logs of PEST Control, Cleaning, and Sanitation.
• Coordinate, improve, and sustain the activities in the quality department with all departments at Globyz Pharma.
• Provide support to Quality management during any product Recall.
• Work with the VP of Quality and Regulatory Affairs Director with a focus on process improvements in the quality area.
• Liaison with customers, suppliers, partners, and other Globyz Pharma departments.

Qualified Person (QP)

• Perform QP duties as per Health Canada regulations and guidance documents.
• Liaison with the supplier of Controlled Drug Substance and the office of Narcotics.
• Maintain Controlled Substance licenses and QP status.
• Report any theft or missing narcotic units to management and Health Canada.
• Where applicable, prepare application and apply for the import and export permits.
• Taking care of Controlled drug Safe at Globyz Pharma and ensure the security during handling Narcotics and Controlled drugs as per established procedures.

Critical Competencies

• Some knowledge in Pharmaceutical Quality Assurance, Quality Compliance, and Quality Systems.
• Product disposition upon the quality inspection; Release or Reject.
• Ability to identify gaps or non-conformances in procedures and documentation upon review.
• Hands-on experience in handling deviation, CAPA, change controls, and customer complaints.
• Knowledge and experience in processes and continuous improvements.
• Strong interpersonal and communication skills (written and oral).
• High proficiency with MS Office applications (Excel, Word, PowerPoint), email, and software.
• Active listener and willing to work as a team member.

Decision Making Authority

• Product disposition, to release or reject product lots based on review of the technical documentation, regulatory compliance, and with the support of quality management.
• Identification and evaluation of deviations, leading investigations with a focus on problem-solving to prevent future occurrences and to ensure the release of quality product by Globyz Pharma for customer use.
• Ability to audit GMP activities to ensure GMP Compliance.
• Ability to identify gaps and non-conformances against current regulations and Globyz SOPs.

Education and Experience

• University degree or College diploma in Life sciences.
• Some background in Pharmaceutical products.
• Some knowledge of Health Canada GMPs and quality regulation during transportation and storage of drug products and handling of Controlled drug products.

Please email your resume to info@globyz.com