Quality Operations Primary Packaging Tier I (Night Shift)

NEPHRON SC, LLC•West Columbia, SC

27d

About The Position

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

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.

Nice To Haves

Minimum of 1 year of pharmaceutical Quality Assurance/Production experience or 2 years related experience preferred. Knowledge of cGMP preferred.

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.
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.
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.