Quality Operations Primary Packaging Tier I (Nights 6:00pm - 6:30am)

Nephron Pharmaceuticals Corporation; West Columbia (SC); On-site; USD 25,000 - 36,000; Full time

Job summary

Nephron Pharmaceuticals Corporation is seeking a QA professional to support weight checks and quality attribute inspections during filling and packaging. You will review batch records for accuracy and ensure regulatory compliance with FDA and cGMP standards.

The role emphasizes documentation, teamwork, and adherence to SOPs while maintaining a clean, safe work environment on the shop floor.

Qualifications

• High School Diploma or GED required.
• 1 year pharma QA/Production experience preferred; knowledge of cGMP is a plus.
• Detail oriented with strong observational skills.
• Proficient with MS Outlook, Word and Excel; basic typing skills.
• Excellent written and verbal communication.
• Ability to manage multiple projects and stay organized.
• Willing to wear PPE and follow safety procedures.

Responsibilities

• Review production batch records for accuracy and completeness.
• Perform weight checks and attribute inspections during production.
• Inspect and release machines and processing rooms for production.
• Maintain quality assurance documentation and training per SOPs.
• Assist with investigations of out of range percentages.
• Promote teamwork and communicate quality observations to QA management.

Skills

Attention to detail

Written communication

Verbal communication

Multi-tasking

Problem solving

Education

High School Diploma or GED

Tools

MS Outlook

MS Word

MS Excel

Job description

Description

Position Summary:

• 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.

Primary Accountabilities:

• 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.

Shop Floor QA Accountabilities:

• 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.

Requirements

Knowledge, Skills & Abilities:

• High School Diploma or GED.
• Minimum of 1 year of pharmaceutical Quality Assurance/Production experience or 2 years related experience preferred. Knowledge of cGMP 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.