Quality Assurance Specialist
- Expired: over a month ago. Applications are no longer accepted.
About Harrow Health, Inc.
Harrow Health, Inc. (Nasdaq: HROW), is a specialty pharmaceutical company focused on the development and commercialization of proprietary and novel sterile and topical drug formulations. We are a rapidly growing company looking to add talented individuals to join our team to help us reach our goals. We have a unique business model and a dedicated group of extraordinary people focused on delivering novel, customizable medicines to physicians and patients TODAY at accessible prices.
The Quality Assurance Specialist will meet the company goals for product quality and production efficiency. This position will ensure that the operations are following the cGMP standards promulgated under Section 503B of the US Food, Drug & Cosmetic Act. The Quality Assurance Specialist will provide guidance for improving production processes for a greater reliability and simplicity. The successful candidate must have the demonstrated ability to build and maintain relationships, trust, and respect with clients, vendors, and peers. Responsibilities include operational and in-process quality oversight of our outsourcing facility in our Ledgewood, NJ location.Responsibilities
Ensure compliance with US Food, Drug & Cosmetic Act, Section 503B, and all of its cGMP elements related to facilities, utilities, warehousing, production, testing, documentation, training, reports and records.Review and approve a variety of complex in-process quality systems documentation in multiple areas including warehouse, staging area, and formulation and filling rooms. This includes:
- Check incoming raw materials or components for conformance to specifications.
- Review/approve raw materials or components for use in production.
- Familiarity with aseptic technique in clean-room environments and gowning in classified areas (ISO 5-8)
- Monitor the production processes to ensure consistency of procedures in controlled environments
- Provide guidance to employees on proper compounding and filling technique and procedures when required.
- Assist in performing AQL visual inspections of finished products
- Perform line clearance and verification of production machine and equipment settings
- Initiate, review and approve quality documentation such as, but not limited to deviations, CAPAs, Change Controls, Root Cause Analysis (RCA), protocols, etc.
- Observe/approve integrity testing of product filters.
- Review the WIFI Loop System and EM Lighthouse Monitoring Alarm Messages routinely.
- General Knowledge of documentation control practices and data trending
- Review logbook entries for completeness.
- Perform duties in accordance with established company procedures and policies; perform other duties as assigned.
A fundamental, working knowledge of safety, quality systems, and quality assurance concepts is required including the application of current Good Manufacturing Practices.
- Familiarity with manufacturing process and operations, automation, equipment/facilities validation.
- Familiarity with FDA inspections and audits
- Investigation writing skills.
- Ability to complete tasks with little direction or need for supervisory follow-up.
- Strong written, verbal and presentation communication skills.
- Strong computer skills in database management and documentation preparation (Word, PowerPoint, Excel, and other must be able to learn additional software as required).
- Ability to think creatively in confronting new issues and pursuing novel approaches to old problems.
- Ability to work under pressure, meet deadlines and exercise sound business judgment with critical thinking skills and high ethical standards.
- Work schedule fexibility
- 5-7 years of progressive experience within cGMP quality operations and FDA regulations or a 503B outsourcing facility, aseptic/parenteral manufacturing/development environment or equivalent technical experience.
Recent experience with validation of aseptic drug product bulk manufacturing process preferred.
- Bachelor’s degree in Science, Microbiology, or Engineering or related field or equivalent work experience required.
Harrow believes in creating long-term relationships by being responsive and relevant and by consistently delivering value to our community of customers. Specifically, with our employees, we focus on attracting, developing and retaining the best talent for our business, challenging our people, demonstrating a “can-do” attitude and fostering a collaborative and mutually supportive environment.
Diversity creates a healthier atmosphere: All qualified applicants will receive consideration for employment without regard to age, ancestry, race, color, religion, sex, national origin, protected veteran status, disability status, marital status, medical condition, genetic information, national origin, gender (including gender identity and expression), or sexual orientation.
Harrow Health is a drug-free workplace. Candidates are required to pass a drug test before beginning employment. In addition, employees in certain positions are subject to random drug testing.
Harrow Health, Inc.
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