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Sr. Quality Compliance Specialist

Harrow Health, Inc.

This is a Contract position in Ledgewood, NJ posted October 15, 2020.

ImprimisRx is one of the nation’s leading ophthalmology compounding businesses ImprimisRx is headquartered in San Diego, CA and operates two production and dispensing facilities based in Ledgewood, New Jersey. ImprimisRx’s 503B outsourcing facility produces formulations for office use in accordance with current good manufacturing practices (cGMP), the highest federal quality standards for drug manufacturers in the country. Its 503A pharmacy produces customizable, patient-specific formulations pursuant to a physician prescription for several chronic care needs. There have been over one million eyes served by the formulations produced at these facilities.Position SummaryThe Quality Assurance Compliance 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 QA Compliance Specialist will participate in audits and inspections and will be responsible for writing and/or managing all deviations, CAPAs, product complaints and change controls at the site.Responsibilities* Participates in regulatory audits, assists in maintenance of audit records and documenting follow-up from audits.* Responsible of writing and/or managing investigations/deviations.* Performs or assists process owners with the root cause analysis.* Responsible of generating and monitoring CAPA’s and change controls for the site.* Prepares and monitors Quality Metrics and KPI’s.* Perform visual inspection of injectable vials.* Performs duties in accordance with established company procedures and policies; performs other duties as assigned.Qualifications* Recent experience with aseptic drug product manufacturing is preferred.* A fundamental, working knowledge of safety, quality systems, and quality assurance concepts is required including the application of current Good Manufacturing Practices and Good Documentation 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 flexibilityExperience* 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.Education/Training* Bachelor’s degree in Science, Microbiology, or Engineering or related field or equivalent work experience required.Supervisory ResponsibilityThis position has no supervisory responsibilities.Position Type and Expected Hours of WorkThis is a full-time position in a compounding pharmacy with regular operations occurring between M-F in our Ledgewood, NJ location. Working hours may vary anywhere from several hours before opening to several hours after closing. Additionally, weekend hours may be needed depending upon workload demands. Rotating shifts as well as holiday and work during inclement weather may be required.TravelNo travel is expected for this position.Physical Demands:* The employee may frequently be required to sit and talk or hear* The employee is required to stand; walk; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch* The employee must occasionally lift and/or move up to 25 poundsWork EnvironmentWhile performing the responsibilities of the job, these work environment characteristics are representative of the environment the job holder will encounter. Reasonable accommodations may be made to enable people with disabilities to perform the essential functions of the job.* May work with hazardous materials and chemicals* Cleanroom environment requires that gowning in the form of hospital scrubs, bunny suits, gloves and steel toe boots be worn. Also, no makeup or jewelry can be worn when working in the clean room environment* Specific vision abilities by this job include close vision, depth perception and ability to adjust focusAAP/EEO StatementImprimis 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 race, color, religion, sex, national origin, protected veteran status, or disability status.ImprimisRx 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.Other DutiesPlease note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time, with or without notice.