Position Title: Quality Control Analyst II
FLSA Status: Exempt
Scope of Job
The QA/QC Analyst will be responsible for following and enforcing cGMP regulations in the Quality unit to ensure compliance.
Receives Direction From:
- Director/Team Leader of Quality Assurance
Provides Direction To (as appropriate): N/A
To include, but are not limited to the following:
- Generate raw material and product specifications
- Perform final quality testing of bulk & finished products in accordance with established procedures.
- Document all instances of rejected product or raw material problems in daily production report.
- Inspect and test incoming raw materials as materials are received.
- Good lab practices/Good documentation practices
- Document appropriate information for quality control reports for each order.
- Create and maintain current files for all quality related correspondence.
- Resolve customer complaints or problems in regard to rejected or non-conforming product.
- Report any unusual discrepancies or problems promptly to management.
- Suggest new testing or inspection methods to minimize inspection efforts required.
- Train co-workers in quality control concepts as requested.
- Perform necessary maintenance of equipment as needed.
- Remain current on quality control practices and trends through publications, seminars, conferences, and related trade shows.
- Perform other related duties as assigned.
- Generate packaging specifications
- Attend development and production meetings
- Create specifications for reagents, components, bulk, and finished goods
- Generate batching/filling records for production
- Review and approve all production/filling records, and any associated test results including the Certificate of Analysis, prepared at Eyenovia Inc. to ensure accuracy of data.
- Responsible for any and all duties and tasks that may be assigned from time to time by the Quality unit and/or senior management.
- Upon request, perform internal walkthroughs and audits to ensure cGMP codes and regulations are being met.
- Maintain and update the Product Code lists (Active and Inactive).
- Maintains documentation on all returned goods (bulk and finished), as well as all disposal of goods (components, bulk and finished).
- Internal audits
- Maintains the deviation tracking log, released lot log, waste disposal log, and the product tracking spreadsheet.
- At the year end, archive the prior year’s finished production files.
- QUALIFICATIONS GUIDELINES
To include, but are not limited to the following:
- Associate degree or higher or equivalent combination of education and experience (Chemistry, Biology-micro background preferred)
- 1 -2 years’ experience in a GMP environment (Medical Devices & Pharmaceuticals)
- Microbiology experience in a sterile or non-sterile environment a HUGE plus
- Ability to set a course of action for the company that will fulfill the vision and expectations proposed by management
- Familiar with validation requirements for medical device and drug products.
- Ability to identify and resolve quality issues early in their life cycle.
- Ability to define and prioritize realistic, specific goals and objectives based on time constraints and resource availability.
- Ability to review and approve physical, analytical and microbial results
- Ability to balance procedures and objectives with attention to detail.
- Ability to build strong relationships, influence others to desired goals, and mentor others.
- Ability to maturely express views and opinions, listen well and accept conflicting points of view.
- Excellent oral/written communication skills
- Excellent organization skills
- Ability to multi-task
- Ability to read and interpret documents such as procedure manuals, work instructions, software manuals; ability to write routine reports and correspondence
- Able to stand, walk and sit for extended periods of time.
- Able to travel by air, rail, car.
- Able to operate personal computer.
- Able to perform light lifting.
- Able to tolerate direct exposure to health and safety hazards associated with the clinical research environment, and with other biological models and materials.
- Any new hire is required to submit proof of full Covid-19 vaccination or a request for a medical or religious exemption by the employee’s first day of employment with Eyenovia.
Training in relation to company systems and procedures, as well as individual job duties will be provided by Eyenovia. The need for additional external training with respect to regulations, industry standards, etc. will be determined by employee’s supervisor, and provided as appropriate.
A file documenting employee training is maintained for each Eyenovia, Inc. employee.
Job descriptions change from time to time. The company retains the right, at its sole discretion, to modify information contained in this job description. Changes in job description will be discussed with the employee at or before implementation.
Eyenovia (NASDAQ:EYEN) is an equal opportunity employer. Eyenovia offers a competitive compensation package including medical/dental/vision, matching 401K, paid time