Quality Operations Secondary Packaging, Shift 3 - Military veterans preferred

Nephron Pharmaceuticals

Description:

Hours: 1800-0630

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, 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, 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:

• Performs Quality Attribute Inspections of the product through the packaging process in compliance with company policies/procedures, FDA and cGMP regulations.

• Ensures the accuracy and completeness of batch records.

• Performs other duties as assigned or apparent.

Primary Accountabilities:

NOTE: The primary accountabilities and the knowledge, skills and abilities listed below, are intended to describe the general content of and requirements for 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

• Reports to Quality Operations Management.

• Responsible for ensuring a high level of employee accountability and performance.

• Responsible for submitting finished product samples as needed.

• Review master batch records and applicable documentation to ensure complete, thorough and accurate data.

• Perform line clearances.

• Support validation and manufacturing studies including special sampling and testing.

• Review and approve production batch records for release into production.

Shop Floor QA Accountabilities:

• Assists with monitoring all production areas and personnel for adherence to all cGMP, SOPs, and safety regulations.

• Assist with development of solutions for chronic problems within quality assurance

• Communicate quality- related observations, issues, problems, discrepancies and any violations of company policies or procedures to Quality Management.

• Adherence to cGMPs is required at all times. All personnel own the quality of what they deliver and are responsible for notifying responsible management in a timely manner of regulatory inspections, serious GMP deficiencies, process deviations, product defects and related actions.

• Stay abreast of current FDA requirements and ensure compliance by familiarity with important department Standard Operating Procedures (SOPs) and routine observance of procedures being performed.

• Assist in other activities (as needed) for Quality Assurance management.

Knowledge, Skills & Abilities:

• Minimum of Highschool diploma or GED

• Preferred - Bachelor of Science degree with 5+ years of pharmaceutical manufacturing or FDA regulated industry experience.

• Knowledge and understanding of cGMP, FDA guidance for pharmaceutical manufacturing, USP, and other applicable regulatory guidance.

• Demonstrated success with process improvements to increase efficiency and effectiveness within a department.

• Proficient with MS Word, Excel, and PowerPoint preferred.

• Excellent written and Oral communication skills.

• Excellent public speaking and presentation skills.

• Must be able to interact with external customers and/ or inspection auditors in a professional manner as well as all internal departments.

• Ability to work independently and be dependable.

• Technical writing skills required.

• The ability to identify work elements in detail, and develop work standards, and work method improvements; develop procedures, and forms to effect method improvement and work simplification.

• Specific expertise, skills, and knowledge within Quality Assurance gained through education and experience.

• The ability and willingness to change direction and focus to meet shifting customer needs and business demands.

• The ability to promote 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 manage many resources and be accurate and current with data and information.

• Position requires standing (10%), sitting (70%), walking (20%), talking, typing and hearing.

• Incumbents are required to wear specified protective equipment as necessary.

• Salary range: Based on experience

• Hours of work: Rotating 12-hour shift, or as needed based on company demand.

• Strong attention to detail.

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, gender identity, age, national origin, disability, status as a protected veteran, pregnancy, marital status, genetic information, childbirth, medical needs arising from pregnancy and childbirth and related medical conditions, including lactation, or any other consideration made unlawful by applicable federal, state or local law.

Nephron Pharmaceuticals is a drug free workplace.

Requirements:

PI239352975