Nephron Pharmaceuticals Corporation
Job title: Nitrile Senior Manager of Quality Compliance
Company: Nephron Pharmaceuticals Corporation
Job description: Description
Nephron Nitrile is a new privately-owned Nitrile Glove manufacturer. Nephron Nitrile products are proudly made in the USA! We are headquartered in West Columbia, South Carolina. The facility utilizes completely automated manufacturing, packaging, and distribution systems, in addition to high volume and redundant utility systems, to ensure production system availability.
· Responsible for compliance with internal procedures, local, state, and federal regulations and guidances at Nephron Nitrile.
· Assessment of the organization’s quality system and compliance status in accordance with all relevant internal procedures, regulations and guidelines.
· Identify and collaborate with management about recommendations, improvements, and/or issues for internal control.
· Assists with additional work duties or responsibilities as evident or required.
· Flexibility to work weekends and overtime, if required.
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.
· Continuously research and review local, state, and federal regulations to ensure industry compliance.
· Ensure organizational compliance by monitoring and tracking daily operations through observation of activities and walkthroughs.
· Conduct internal audits to ensure compliance with internal operating procedures and other applicable regulatory requirements.
· Input data of the audit process in TrackWise® Digital.
· Devise and execute annual audit plan.
· Lead internal audits opening and closing meetings.
· Devise audit scope and agendas.
· Identify and summarize audit findings as well as notify appropriate management.
· Obtain and verify audit corrective action responses.
· Prepare and review final audit reports.
· Assist and summarize audit effectiveness checks.
· Participate as needed during external audits/inspections.
· Devise and implement inspection readiness activities.
· Review and update Quality Compliance documentation.
· Salary range: Based on experience.
· Hours of work: Monday thru Friday on an 8-hour shift, or as needed based on company demand.
Knowledge, Skills, & Abilities:
· Regionally accredited business-related degree or equivalent work experience.
· 3 years pharmaceutical experience preferred.
· Experience with FDA inspections and other regulatory agency inspections.
· Thorough knowledge of cGMP and associated regulations, 21 CFR Part 11, and 820.
· Proficient in MS Word, Excel, PowerPoint, and TrackWise®.
· Proficient written and oral communication skills.
· Must be a team player and able to interact with all departments.
· Promote quality improvements. .
· A broad perspective that aligns decisions to organizational objectives and long-term consequences of day-to-day activities.
· The ability to take strategic objectives and accept accountability to drive results through effective actions.
· The ability and willingness to change direction and focus to meet shifting organizational and business demands.
· The ability to set clear targets and use performance measures to assess risk and opportunities in order to effectively manage the assets of the business.
· The ability to create and contribute to an environment that values people, encourages trust, teamwork, and open communication, and provides participation, learning, feedback and recognition.
· The ability to effectively manage one’s self, demonstrates integrity, be productive under pressure, and achieve development goals.
· The ability to take strategic objectives and accept accountability; motivates and influences others, think globally and leverage diversity.
· The ability to manage a multitude of resources and to be accurate and current with data and information.
· Position requires lifting (up to 40lbs), vision (20/20), standing (10%), sitting (40%), walking (50%), typing, talking and hearing.
· Comply with proper gowning, PPE requirements and other non-specified protective equipment as necessary.
· Wear safety glasses, hearing protection, bouffant, and laboratory coats and other non-specified protective equipment as necessary.
Nephron Nitrile 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 Nitrile and is a drug free workplace.
Location: West Columbia, SC
Job date: Sun, 07 May 2023 07:48:41 GMT
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