Nephron Nitrile-QA Online-Tier I- Nights 6:00 PM to 6:30 AM
Nephron Pharmaceuticals Corporation
- West Columbia, SC
- Permanent
- Full-time
- Performs Weight Check and Quality Attributes Inspection of the product through the packaging process in compliance with company policies / procedures, FDA and cGMP regulations.
- Ensures the accuracy and completeness of lot records.
- Performs other duties as assigned or apparent.
- Successfully complete QA OJT packet.
- Successfully complete LBR (General Use), training.
- Successfully complete DEA certification.
- Review production lot records for GDP accuracy.
- Monitor and perform start up, in-process and finished product inspections including weighing, attribute inspections during production.
- Maintain quality assurance documentation.
- Promote teamwork both within the QA area and other departments.
- Monitor all production areas and personnel for adherence to all GMP, SOP's and safety regulations.
- Keep line and work station clean and orderly.
- Verify incoming packaging materials, raw material chemicals, in process and finished products.
- Ensure no product line contamination.
- Perform line clearances including equipment, components and label verification.
- Inspect and release machines and processing rooms for production.
- Support validation and manufacturing studies including special sampling and testing.
- Organize workload during lot changeovers for efficient execution.
- Review and approve production lot records for release into production.
- Release finished product for packaging.
- Investigate out of range percentages.
- Communicate quality- related observations, issues, problems, discrepancies and any violations of company policies or procedures to QA Management or Designee.
- Review all completed production lot record documentation to ensure completeness and compliance.
- High School Diploma or GED.
- Minimum of 1 year of pharmaceutical/medical device Quality Assurance/Production experience or 2 years related experience preferred. Knowledge of GMP 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 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.