Administers/Supports/Facilitates core processes of the Quality Management System (QMS) in accordance with international standards, regulatory requirements, customer requirements, and BioGX’s standard operating procedures herein referred to as “QMS requirements”.
Essential Duties and Responsibilities (other duties may be assigned):
Administers/Supports/Facilitates assigned quality related activities within the organization, including but not limited to the maintenance of BioGX’s QMS, supplier performance management, corrective action, preventive action, training management, device & equipment maintenance management and performance monitoring activities required to maintain compliance to QMS requirements.
Administers/Supports/Facilitates supplier management activities, including supplier selection, evaluation, and re-evaluation. Monitors processes involving the evaluation of purchased components and the dispositioning of purchased components found to be nonconforming in accordance with QMS requirements.
Administers/Supports/Facilitates approved supplier lists (ASL) and approved material lists (AML).
Data updating;Review regularly for suitability and accuracy; Self-assessment, survey, nondisclosure agreements (NDA), quality plan agreements (QPA) distribution and follow-up; Update ASL as directed; Process supplier corrective action (SCAR) requests; Maintain supplier related databases and records as assigned
Administers/Supports/Facilitates document control and procedure development processes in accordance with QMS requirements.
Administers/Supports/Facilitates corrective and preventive action processes in accordance with QMS requirements.
Follow-up through completion;Effectiveness checks
Administers/Supports/Facilitates equipment management processes to include preventive maintenance and calibration activities in accordance with QMS requirements.
Administers/Supports/Facilitates compliance monitoring activities to include environmental monitoring, material evaluation and acceptance, product evaluation and acceptance, receipt and disposition of nonconforming material/product, equipment maintenance and calibration, equipment qualification, material and product traceability, material and product identification, risk mitigation, supplier performance monitoring, product realization, record control including good documentation practices and other BioGX processes.
Administers/Supports/Facilitates with risk management processes and supporting activities.
Administers/Supports/Facilitates with reviewing and reporting QMS performance objectives and supporting activities.
Administers/Supports/Facilitates with QMS auditing processes and supporting activities.
Maintain audit related records
Ensures all QMS records are complete, legible, protected and retrievable.
Other duties as assigned.
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.
Excellent verbal and written communication skills
Interdisciplinary team building experience involving scientists, engineers, quality assurance, manufacturing, marketing and other participants in the medical device industry.
Working knowledge of cGMP, international standards, and Quality Assurance systems.
Strong computer skills having advanced knowledge and experience with current word processing (MS Word), spreadsheet (MS Excel), graphical, and file management software.
Proficient in typing and keyboard topology.
Extremely detail-oriented with strong organizational skills and high-quality standards
Education and Experience:
Bachelor of Science Degree from a four-year accredited college or university; or two or more years related experience and/or training.
Language Skills: Must be proficient in writing, and communicating in the English language.
Mathematical Skills: Must be consistent with level of education.
Reasoning Ability: Good problem solving, judgment and decision-making skills are required.
Certifications, Licenses, Registrations: None required.
Physical Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Work entails regularly performing tasks while working at a computer, desk, laboratory bench or automated machine. Work may involve occasional climbing or balance. Work entails occasional lifting and/or moving up to 25 pounds. Work occasionally requires travel between buildings. This is typically completed by foot or by car.
The employee’s sensory modalities (vision, hearing, smell) and physical capabilities (ambulation without mechanical assistance, strength, coordination, dexterity, range of motion) must be sufficient to independently perform duties/functions of the position.
Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
This position will involve a combination of office and biotechnology laboratory environments. While performing the duties of this job, the employee may be exposed to hazardous chemicals, blood borne pathogens, automated equipment, and high levels of noise and vibration. The noise level in the work environment is usually moderate.’