Quality Operations – Cleanroom QA Coordinator at Nephron Pharmaceuticals in West Columbia, South Carolina

Job Description:

Corporate Statement

Nephron Pharmaceuticals Corporation is a privately-owned global leader in the manufacturing of generic drug products, over-the-counter (OTC) drug products and medical devices. Nephron' s products are sterile, preservative and additive free and proudly made in the USA! We are headquartered in West Columbia, South Carolina. Our location provides the ability to develop new devices and medications including respiratory therapies, ophthalmics, and injectables, for in-house or contract manufacturing opportunities. The facility utilizes completely automated manufacturing, packaging, and distribution systems, in addition to high volume and redundant utility systems, to ensure production system availability. Nephron specializes in Blow-Fill-Seal (BFS) manufacturing, a niche technology that allows a vial of medication to be formed, filled and sealed in a continuous process, in a sterile, enclosed environment and without human intervention.

As an industry leader in product safety and quality, Nephron produces a variety of inhalation solutions, and has distributed over 1 billion doses of respiratory medication per year since 2009. Nephron is currently working on research and development projects that include over 50 new products. The company's longstanding relationships with major drug wholesalers allow us to distribute our products to retail pharmacies, mail order pharmacies, hospitals, home care companies, and long-term care facilities. Nephron has a sales force that covers all fifty states and Puerto Rico, with additional sales channels throughout South America, the Middle East, and Europe. Nephron exists to provide top-quality, affordable medications to everyone.

Position Summary:

The Cleanroom QA Coordinator is an expert in the QA Functions as they relate to Aseptic Technique, Formulation and Filling Operations that are performed in classified and clean unclassified environments as a Clean Room QA - Tier I and Clean Room QA - Tier II. Cleanroom QA Coordinator must maintain gown certification, have a strong grasp of applicable SOP's, aseptic techniques, gowning practices and be knowledgeable of the cleanroom environment. The Cleanroom QA Coordinator must maintain an ISO5 Gown Certification, assist with daily review of Master Batch Records or Electronic Batch Records to ensure completion and identify needed corrections. Responsible to write quality investigations to successfully determine root cause(s) and create robust corrective and preventive actions as required. The Cleanroom QA Coordinator will verify paperwork, verify the production schedule, run errands, print, fax, handles purchase orders, communicate with departments, review department personnel making sure everybody is doing an adequate job, and work flexible hours if needed. A Cleanroom QA Coordinator must hold cGMP and Nephron's core beliefs. This position is for current employees with at least 9 months of experience as a Cleanroom QA - Tier II.

Primary Accountabilities:

NOTE: The primary accountabilities below are intended to describe the general content of and requirements of this position and are not intended to be an exhaustive statement of duties. Incumbents may perform all or most of the primary accountabilities listed. Specific tasks or responsibilities will be documented in the incumbents' performance objectives as outlined by the incumbents' immediate supervisor or manager.

· Perform administrative duties daily review of EBRs and MBRs for accuracy and completion, filing documentation, Managing Trackwise Digital records, errands, scheduling, inventory, etc.

· Organize and Assist with Managing Cleanroom QA personnel.

· Write or update batch records, SOP's, Deviations, IR's NCR's and CAPA's.

· Perform Effectiveness Verifications

· Assist with overseeing training of new hires and existing employees.

· Participate in new project development as needed.

· Assist Cleanroom QA Department as needed.

· Monitor Cleanroom QA personnel to ensure proper compliance to procedures, processes, regulations and policies providing real time corrections and feedback when available.

· Draft and Execute re-trainings as needed or when improper technique has been observed.

· Work with management on additional work duties or responsibilities as evident or required.

Knowledge, Skills & Abilities

· Minimum High School Diploma or equivalent.

· Previous manufacturing/production work experience preferred.

· Gowning Certification preferred.

· Detail oriented and ability to work independently or as a team.

· Must have strong organizational and time management skills, and must be able to multi-task.

· Previous sanitizing experience in Aseptic Processing preferred.

· Incumbent must be able to work 12-hour days without fatigue.

· Ability to climb ladders.

· Incumbents are required to perform full range of motion in fingers, wrists, elbows and shoulders.

· The ability and willingness to change direction and focus to meet shifting organizational and business demands.

· The ability to create and contribute to an environment that values people, encourages trust, teamwork, and open communication, and provides participation, learning, feedback and recognition.

· The ability to effectively manage oneself, demonstrates integrity, be productive under pressure, and achieve development goals.

· The ability to take strategic objectives and accept accountability, motivate and influence others.

· The ability to manage a multitude or resources and to be accurate, organized and current with data and information.

· Position requires, bending, lifting (up to 20 lbs.), reaching overhead for extended periods of time, visual acuity, and standing, sitting and walking.

· Incumbents are required to wear safety glasses/face shields, hearing protection, bouffant, respirator, tyves coveralls and other non-specified protective equipment as necessary for extended periods of time.

· Salary range: Based on experience.

EEO Statement:

Nephron is an equal employment opportunity employer and does not discriminate against employees or job applicants on the basis of race, religion, color, sex, sexual orientation, age, national origin, mental or physical disability of a qualified individual, veteran or military status, pregnancy, marital status, familial status, genetic information, or any other consideration made unlawful by applicable federal, state or local law.

Nephron Pharmaceuticals is a drug free workplace.

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