BioGX is a global molecular diagnostics company focused on the health and safety of communities all over the world. We design, develop and manufacture products and devices for Clinical, Water Quality, Food Safety and Pharma Quality. We are headquartered in Birmingham, AL.
This position supports the Director of Operations in ensuring all quality related matters are addressed accurately in a timely manner. The position will require in depth investigation skills, root cause analysis, and robust Corrective Action Preventive Action (CAPA) implementation.
Essential Duties and Responsibilities:
● Responsible for ensuring all activities related to the recognition, investigation and resolution of non-conformities are performed on a timely manner and in compliance with company and regulatory requirements
● Accountable for reviews and evaluations for completeness and compliance of the investigation reports and resolution plans authored by Subject Matter Experts (SMEs) and other company personnel.
● Efficiently follow up and verifies that corrective / preventive actions are appropriate, are implemented as planned and have the intended effectiveness.
● Responsible for ensuring Corrective & Preventative Actions are appropriate, are implemented as planned and have the intended effectiveness.
● Accountable for supporting the CAPA and Customer Complaints programs as requested by Manager.
● Proficiently lead and participate directly in the investigation of Deviations/Non-Conformances.
● Effectively and efficiently write Deviations/Non-Conformances investigation reports.
● Responsible for identifying recurring Deviations /Non-Conformances and ensures appropriate actions are taken such as Management and Regulatory Notifications
● Accountable for delivering training related to CAPA, Root Cause Analysis and quality investigations to company employees
● Proficiently perform or facilitate quality investigations when necessary
● Responsible for reporting any deviations to procedures, specifications or systems to the Supervisor with logic, data and possible corrective measures
● Accountable for working with problems associated with a wide variety of quality issues that could range from errors in production, incomplete batch records, component reconciliation, poor documentation practices, etc
● Proficiently deal with problems associated with dealing with individuals from departments, and working on various functions within and outside the company
● Providing a strong ability to influence others while maintaining integrity and trust, by keeping a continuous focus on effective communications to ensure achievement of shared goals.
● Responsible for developing SOP’s as needed
● Accountable for participating in the internal audit program.
● Other duties as assigned.
Supervisory Responsibilities: This position does not require supervisory responsibilities at this time.
Qualifications: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
● Bachelors Degree in Chemistry or related discipline.
● Minimum 3 years’ experience in the pharmaceutical or medical device industry in Quality Assurance or Quality Control department.
● Minimum 2 years’ experience in conducting investigations, writing Quality Deviations, Complaints, CAPAs, and Change Control in a pharmaceutical or medical device industry.
● Excellent communication skills, both written and verbal, in combination with strong interpersonal skills and demonstrated technical writing skills.
● Strong proven understanding of Pharmaceutical or Medical Device Operations
● Excellent detailed knowledge of cGMP, GDP, and FDA regulations
● Strong ability to work in a fast-paced environment and prioritize workload accordingly
● Proficiency with Microsoft Word, Excel, PowerPoint
Education and Experience: A bachelor’s degree from an accredited university in the field of Chemistry or a related discipline. At least three years of professional experience in Quality Assurance or Quality Control.