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.
Purpose of the Position:
Provide Quality Assurance (QA) functions in accordance with international standards, regulatory requirements, customer requirements, and BioGX’s quality management system requirements herein referred to as “QMS requirements”. Review quality control evaluation reports to make determination whether manufactured/processed products meet defined acceptance specifications prior to release. Provide support for the review and oversight of stability studies for manufactured products.
Essential Duties and Responsibilities(other duties may be assigned):
- Oversee and perform quality assurance (QA) material acceptance functions and product release functions to ensure components and finished product meet defined quality control requirements and specifications prior to release. Review documented evaluation results to determine final acceptance of critical raw materials and final release of finished product.
- Track and report quality assurance and product performance metrics.
- Investigate out of specification results and prepare a final investigation report.
- Prepare certificates of conformance (CofC) and certificates of analysis (CofA) for finished products as needed.
- Product Stability Control:
- Create and initiate stability plans across the organization in accordance with defined procedures, standards, and regulatory requirements.
- Review stability study interval evaluations for materials and products in accordance with defined procedures and stability plans. Sufficiently document interim and final data results.
- Prepare stability study final reports as needed for supporting product stability claims.
- Oversee communication of current stability claims.
- Resolve product stability inquiries.
- Carry out work to company standards, including documentation, accurate record keeping, and maintaining related work schedules in order to support product development timelines.
- Present documented results as required. Proposes new strategies and methods to address immediate and upcoming technical issues.
- All documentation is prepared in accordance with good documentation practices (GDP) as prescribed by the quality management system.
- Serve as the Process Owner for processes assigned by the BioGX Job Function Training Matrix and is responsible for the effective execution and relevancy of each documented process assigned
- Performs additional tasks as assigned.
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.
- Working knowledge and/or experience with genetic technologies, gene amplification, qPCR, etc.
- Excellent verbal and written communication skills
- 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’s degree in Chemistry, Molecular Biology or a related field. Advanced degree desired. Equivalent combination of education and Molecular Diagnostics experience will be considered. 1-3 years of quality experience in pharmaceutical, medical device or other related industries desired.
Must be proficient in writing and communicating in the English language.
Must be consistent with level education.
Good problem solving, judgment and decision making skills are required.
Certifications, Licenses, Registrations:
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. 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.
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.