Description

Position Summary: 

• Perform visual inspection of injectable products in compliance with company policies/procedures, FDA and cGMP regulations

• Maintains quality assurance documentation by ensuring the accuracy and completeness of batch records. 

• Promotes teamwork both within the QA Team and other departments. 

• Monitor all packaging areas and personnel for adherence to all cGMP, SOP's and safety regulations. 

• Keep line and work station clean and orderly. 

• Perform line clearance including equipment, components and label verification.

• Communicate quality- related observations, issues, problems, discrepancies and any violations of company policies or procedures to the Supervisor. 

• Specific expertise, skills and knowledge within quality assurance gained through education and experience. 

• The ability and willingness to change direction and focus to meet shifting organizational and business demands. 

• Able to handle diversity of projects.

• 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. 

Primary Accountabilities: 

• Monitors and performs finished product attribute inspections. 

• Performs visual inspections of Outsourcing products if deemed necessary or required.

• Supports secondary packaging operations by performing QA verifications of packaging, label verifications, etc.

• Maintains quality documentation and review to ensure completion and compliance.

• Promotes teamwork both within the QA Team and other departments.

• Keep line and work station clean and orderly.

• Ensure that there is no cross contamination.

• Perform line clearances. 

• Support validation and manufacturing studies including special sampling and testing. 

• Organize workload during lot changeovers for efficient execution.

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.

NOTE: The primary accountabilities and the knowledge, skills and abilities listed below, are intended to describe the general content of and requirements for this position and are not intended to be an exhaustive statement of duties. Incumbents may perform all or most of the primary accountabilities listed. Specific tasks or responsibilities will be documented in the incumbents’ performance objectives as outlined by the incumbents’ immediate supervisor or manager.

Knowledge, Skills & Abilities: 

• High School Diploma or GED 

• Detail oriented

• 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. 

• Good computer skills in MS Outlook, MS Word, MS Excel, internet, email and basic typing skills. 

• Good written, oral and comprehensive communication skills. 

EEO Statement: 

Nephron is an equal employment opportunity employer and does not discriminate against employees or job applicants on the basis of race, religion, color, sex, sexual orientation, gender identity, age, national origin, disability, status as a protected veteran, pregnancy, marital status, genetic information, childbirth, medical needs arising from pregnancy and childbirth and related medical conditions, including lactation, or any other consideration made unlawful by applicable federal, state or local law. 

Nephron Pharmaceuticals is a drug free workplace.