Nephron Pharmaceuticals · 2 weeks ago
Quality Operations Clean Room Technician Tier I
West Columbia, SC
Full-time
Onsite
Entry Level
1+ years expNephron Pharmaceuticals is seeking Quality Operations Clean Room Technicians Tier I to monitor filling operations in compliance with company policies and regulatory standards. The role involves ensuring accuracy in batch records, performing personnel monitoring, and maintaining quality assurance documentation.
BiotechnologyHealth CareManufacturing
Responsibilities
Monitors aseptic techniques of personnel within the clean room
Monitor Outsourcing filling operations within the clean rooms
Verifies syringe filling rejects of Outsourcing products and performs quality attribute inspections as needed
Maintains quality assurance documentation
Review/sign appropriate sections designated for Pharmacist/QA designee signatures within the batch records
Promotes teamwork both within the QA Team and other departments
Monitors all filling areas and personnel for adherence to all cGMP, SOP’s and safety regulations
Keep line and work station clean and orderly to ensure no product line contamination
Perform line clearance including equipment, components and label verification
Perform room releases for filling rooms for Outsourcing areas
Communicate quality – related observations, issues, problems, discrepancies and any violations of company policies or procedures to the Supervisor/Management
Review all completed production batch record documentation to ensure completion and compliance
Reviewing Logbooks for GDP and accuracy
Performs general operation QA functions for manual filling processes
Ability to perform personnel monitoring within the clean room
Trained and authorized to enter samples into LabVantage
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
Minimum of 1 year of pharmaceutical Quality Assurance/Production experience or 2 years related experience preferred
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 board 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
Incumbents are required to wear hearing protection and other non-specified protective equipment as necessary
Preferred
Knowledge of GMP 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