Nephron Pharmaceuticals · 16 hours ago
Quality Operations Primary Packaging Tier I (Shift 1 6:00 am to 6:30 pm)
West Columbia, SC
Full-time
Onsite
Entry Level
1+ years expNephron Pharmaceuticals is a company focused on quality assurance in the pharmaceutical industry, and they are seeking a Quality Operations Primary Packaging Tier I. The role involves performing quality checks and inspections during the filling and packaging process to ensure compliance with regulations and company standards.
BiotechnologyHealth CareManufacturing
Responsibilities
Performs Weight Check and Quality Attributes Inspection of the product through the filling and 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
Successfully complete required Quality Assurance Training as outlined per procedure
Successfully complete DEA certification
Review production batch records for accuracy and completeness
Monitor and perform start up, in-process and finished product inspections including weight checks and attribute inspections during production
Maintain quality assurance documentation
Promote teamwork both within the QA area and other departments
Keep line and work station clean and orderly
Inspect and release machines and processing rooms for production
Support validation and manufacturing studies including special sampling and testing
Organize workload during lot and batch changeovers for efficient execution
Review and approve production batch records for release into production
Investigate out of range percentages
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
Qualification
Required
High School Diploma or GED
Detail oriented
Good computer skills in MS Outlook, MS Word, MS Excel, internet, email and basic typing skills
Good visual acuity and observation skills
Good written, oral and comprehensive communication skills
Able to handle diversity of projects
Specific expertise, skills and knowledge within quality assurance gained through education and experience
A broad perspective that aligns decisions to organizational objectives and long-term consequences of day-to-day activities
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 effectively manage one self, demonstrates integrity, be productive under pressure, and achieve development goals
Position requires reaching (waist to head), bending (waist to floor), lifting (up to 25 lbs.), reaching (waist to head), vision (20/20), standing (40%), sitting (20%), walking (40%), typing, and hearing
Incumbents are required to wear hearing protection and other non-specified protective equipment as necessary
Preferred
Minimum of 1 year of pharmaceutical Quality Assurance/Production experience or 2 years related experience preferred
Knowledge of cGMP preferred
Company
Nephron Pharmaceuticals
Nephron Pharmaceuticals Corporation is a mid-sized company that manufactures generic respiratory medications.
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