Quality Assurance & Regulatory Affairs Specialist
Focus Laboratories Maumelle, AR
- Expired: over a month ago. Applications are no longer accepted.
FOCUS Laboratories is a specialty eye care pharmaceutical company that is dedicated to providing innovative, high quality medications and treatments to eye care providers that will improve the quality of the life of their patients.
Aides in the implementation and maintenance of the quality management system in accordance with local, national and international laws, regulations and other requirements. This position is intended to support the Director of Quality Assurance and Regulatory Affairs with regulatory affairs as well as with other duties and projects as needed. The QA/RA Specialist supports management by providing guidance on matters of quality and regulatory concern in reference to business planning activities. The QA/RA Specialist researches requirements in new markets and keeps current on existing requirements as products are distributed. Along with the Director of Quality Assurance and Regulatory Affairs, represents and supports the company to external business partners, as required.
ESSENTIAL DUTIES & RESPONSIBILITIES
Supports efforts on behalf of the Director of Quality and Regulatory Affairs to build and maintain aspects of the quality assurance and regulatory programs
- Take ownership or supports activities over the following processes as designated by the Director of Quality Assurance: Change Control, Corrective and Preventive Actions, Supplier Management, Complaint Handling, Training, Nonconformance Control, Process Deviations, Auditing, Batch record review.
- Acts as the primary resource for validation activities associated with facility control. Review the quality system for continuous improvement opportunities
- Suggests and initiates quality process improvements in areas of identified deficiencies.
- Update processes and practices in response to a changing regulatory environment.
- Aides in communications to regulatory authorities
- Supports the Director of Quality Assurance and Regulatory Affairs in representing Focus Laboratories during audits
- Prepares and manages communications and updates to regulatory agencies as follow-up to recalls, corrective actions, etc.
Responsible for the performance of regulatory functions as listed below
- Evaluation of significant changes to Focus Laboratories product and processes and follows up with appropriate regulatory action including verification activities, notification to regulating bodies, etc.
- Evaluating events/incidences and reporting on them to regulatory authorities as required.
- Maintenance and upkeep of regulatory documentation.
- ￼￼￼As requested by the Director of Quality Assurance and Regulatory Affairs, facilitates project planning, communicates to management, and reviews documentation.
- Aides in process development
- Ensures that design control activities are carried out and appropriately documented.
- Along with the Director of Quality Assurance and Regulatory Affairs helps determine the requirements for the roll-out of new product development and maintenance.
- Works with contractors and cross-functional teams to ensure the safe design and manufacture of product throughout the product life cycle.
NON-ESSENTIAL DUTIES & RESPONSIBILITIES
- Participate in business planning and process implementation as needed.
- Continue education in medical device, pharmaceutical, dietary supplement and cosmetic industry practices.
- Other duties as assigned
- May include occasional travel by car or by airplane.
- Must be able to remain in a stationary position for long periods of time.
- Needs to occasionally move about inside the office to access file cabinets, and other equipment, etc.
- Constantly operates a computer and other office productivity machinery, such as a calculator, copy machine, and computer printer.
- Required to have close visual acuity to perform an activity such as: preparing and analyzing data and figures; transcribing; viewing a computer terminal; extensive reading.
- At least 2 years experience working in the management of quality systems
- Bachelor’s Degree required (preferably in a scientific field) or equivalent in work experience
- Industry knowledge/background is preferred
Knowledge, Skills, and Abilities:
- Ability to communicate both verbally and in writing in a business-like and concise manner
- Ability to interpret and act accordingly to regulations
- Proficiency with Microsoft Excel and Word software programs
- Highly motivated, committed and responsible, with a commitment to ethical business practices
- Requires a valid driver’s license and ability to use own transportation for business travel
- Ability to work independently and as part of a team efficiently to meet deadlines
- Ability to work full-time in our Little Rock, AR office
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