Quality Operations Visual Inspector - Tier I (All Shifts) at NEPHRON SC, LLC

West Columbia, South Carolina, United States -

Full Time

Start Date

Immediate

Expiry Date

16 Jun, 26

Salary

0.0

Posted On

18 Mar, 26

Experience

0 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Visual Inspection, Quality Assurance, cGMP Regulations, Batch Records, Teamwork, SOPs, Safety Regulations, Line Clearance, Communication, Integrity, Detail Oriented, Computer Skills, MS Outlook, MS Word, MS Excel, Typing

Industry

Pharmaceutical Manufacturing

Description

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.

Responsibilities

The primary duties involve performing visual inspections of injectable products in compliance with regulations and maintaining quality assurance documentation for accuracy and completeness. This includes monitoring packaging areas for adherence to cGMP and SOPs, performing line clearances, and communicating quality observations to the supervisor.