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Description
Job Title: Quality Operations Secondary Packaging Tier I
Reports To: Quality Operations Secondary Packaging Supervisor
FLSA Status: Non-Exempt
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Corporate Statement
Nephron Pharmaceuticals 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. 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. Our quality first culture is built on:
Transformation,
Execution and
Trust.
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Job Purpose
Ø Performs Quality Attribute Inspections of the product through the packaging process in compliance with company policies/procedures, FDA and cGMP regulations.
Ø Ensures the accuracy and completeness of batch records.
Ø Performs other duties as assigned or apparent.
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Essential Duties And Responsibilities
Ø Review Batch Records and applicable documentation to ensure complete, thorough and accurate data.
Ø Responsible for ensuring a high level of employee accountability and performance.
Ø Maintains quality assurance documentation including shift pass downs.
Ø Keep QA work station clean and orderly.
Ø Perform packaging line clearances.
Ø Pull Retain, Stability, and Lab samples.
Ø Perform or verify Quality Finished Product Attribute Inspections.
Ø Perform AQL Calculations.
Ø Verify component Exhibits
Ø Verify all documents are present within the batch record.
Ø Support validation and manufacturing studies, including special sampling and testing.
Ø Communicate with Management any quality issues identified with product
Supplemental Functions
Ø Assists with monitoring all production areas and personnel for adherence to all cGMP, SOPs, and safety regulations.
Ø Assist with development of solutions for chronic problems within quality assurance
Ø Communicate quality- related observations, issues, problems, discrepancies and any violations of company policies or procedures to Quality Management.
Ø Adherence to cGMPs is required at all times. All personnel own the quality of the product delivered and are responsible for notifying responsible management in a timely manner of regulatory inspections, serious GMP deficiencies, process deviations, product defects and related actions.
Ø 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.
Ø Assist in other activities (as needed) for Quality Assurance management.
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Skills
Job Specifications and Qualifications:
- Detail oriented.
- Technical writing skills required.
- Good written, oral and comprehensive communication skills.
- Operating computer and relevant software;.
- Must be proficient in MS Word, Excel, and PowerPoint;
Abilities
- 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 one’s self, demonstrates integrity, be productive under pressure, and achieve development goals.
- Ability to handle contending priorities and managing partner expectations
- The ability and willingness to change direction and focus to meet shifting organizational and business demands.
- Assist in other activities (as needed) for Quality Operations management.
- Must have the ability to make recommendations to effectively resolve problems or issues by using judgment that is consistent with applicable standards, practices, policies, procedures, regulation or government law.
- 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.
Education/Experience
- Minimum of High School Diploma or GED required.
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Working Conditions / Physical Requirements
- This position requires bending, typing, lifting (up to 25 1bs.), standing, sitting and walking throughout the facility.
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The intent of this job description is to provide a representative summary of the types of duties and responsibilities that will be required of the positions given this title and shall not be construed as a declaration of the specific duties and responsibilities of any particular position. Employees may be requested to perform job-related tasks other than those specifically presented in this description.
Nephron Pharmaceuticals 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.
