Nephron Pharmaceuticals · 1 month ago
QO Secondary Packaging Tier I (Shift 2: 1400 - 2230 M-F)
West Columbia, SC
Full-time
Onsite
New Grad, Entry LevelNephron Pharmaceuticals is a privately-owned global leader in the manufacturing of generic drug products and medical devices. The QO Secondary Packaging Tier I role is responsible for performing quality inspections during the packaging process and ensuring compliance with FDA and cGMP regulations.
BiotechnologyHealth CareManufacturing
Responsibilities
Perform 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
Review Batch Records and applicable documentation to ensure complete, thorough and accurate data
Responsible for ensuring a high level of employee accountability and performance
Maintains quality assurance documentation including shift pass downs
Keep QA work station clean and orderly
Perform packaging line clearances
Pull Retain, Stability, and Lab samples
Perform or verify Quality Finished Product Attribute Inspections
Perform AQL Calculations
Verify component Exhibits
Verify all documents are present within the batch record
Support validation and manufacturing studies, including special sampling and testing
Communicate with Management any quality issues identified with product
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 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
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
Qualification
Required
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
Minimum of High School Diploma or GED required
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
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
Company
Nephron Pharmaceuticals
Nephron Pharmaceuticals Corporation is a mid-sized company that manufactures generic respiratory medications.
Founded in 1997
501-1000 employees
H1B Sponsorship
Nephron Pharmaceuticals has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (5)
2024 (2)
2023 (1)
2022 (1)
2021 (2)
2020 (1)
Funding
Current Stage
Late StageTotal Funding
$775MKey Investors
WhiteHawk Capital Partners
2025-01-10Debt Financing· $350M
2023-09-15Private Equity· $350M
2014-08-07Debt Financing· $75M
Leadership Team
B
Bryan Beck
Chief Technology Officer
A
Ashley Daugherty
Chief Scientific Officer
Recent News
PR Newswire UK
2025-10-20
Company data provided by crunchbase