Validation Specialist

Corporate Statement

Nephron Pharmaceuticals Corporation is a privately owned global leader in the manufacturing of generic respiratory medications. All Nephron’s products are proudly made in the USA! Our facility provides the ability to develop new devices and medications including respiratory therapies, ophthalmic, 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 that will ensure production system availability. Nephron specializes in blow-fill-seal (BFS) manufacturing, a technology that allows a vial of medication to be formed, filled and sealed in a continuous process without human intervention, and in a sterile, enclosed area.

Position Summary:

· Coordinate, perform and oversee qualification and validation activities.

· Assists with additional work duties or responsibilities as evident or required.

· Performs other duties as assigned or apparent.

Primary Accountabilities:

· Write installation, operational and performance qualification protocols for production equipment, laboratories (Micro & Chemist) and process validation for production processes as required and based on experience. Write new Standard Operating Procedures for department use.

· Execute and/or coordinate execution of validation protocols with R&D engineers, engineering personnel, quality assurance, production personnel and/or (Micro & Chemist) laboratories. Write summary reports for the completed qualifications including recommendations for process improvements.

· Perform statistical analysis.

· Provide support to Validation Management to complete validation activities and keep company in FDA compliance.

Knowledge, Skills & Abilities:

NOTE: The primary accountabilities and the knowledge, skills and abilities listed 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 below. Specific tasks or responsibilities will be documented in the incumbents’ performance objectives as outlined by the incumbents’ immediate supervisor or manager.

· Bachelor’s Degree in Science (4 year) from regionally accredited university or Associate Arts Degree (2 year) and 3 plus years of relevant experience.

· Work experience in clean room. Need to have cGMP knowledge. Must follow SOP and validation protocols.

· Microsoft Word, Power Point, Excel, Access, Minitab. Good communication and interpersonal skills. Organizational Skills.

· Specific expertise, skills and knowledge within quality assurance gained through education and experience.

· The ability to take strategic objectives and accept accountability to drive results through effective actions.

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

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

· The ability to take strategic objectives and accept accountability, motivate and influence others thinks globally and leverages diversity.

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

· Position requires bending, typing, climbing, lifting, reaching, vision, standing, sitting (60%), walking, and hearing.

· Additional Requirements:

· 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.