Quality Senior Specialist - 12-Hr Night Shift 2-2-3

Alcami Corporation • Morrisville, NC

7d • Onsite

About The Position

The Quality Senior Specialist provides on-site quality support in a fast-paced environment, performing varied activities to ensure quality and compliance with applicable regulatory requirements. The role reviews documents and data relevant to laboratory, manufacturing, compliance, or regulatory processes; supports audits and inspections; consults on quality and compliance matters; maintains quality databases; performs trend analysis as needed; and develops or delivers quality and compliance training. The position also develops SOPs and other quality documents as needed.

The Quality Senior Specialist applies independent thought, practical troubleshooting, and problem-solving with some supervision. The role serves as a model for adherence to GMP and regulations across departments, exercises judgment within defined procedures and practices, and escalates issues when needed. This is a 100% on-site role with a 12-hour rotating night shift schedule, 2-2-3, from 7:00 p.m. to 7:00 a.m. Travel of up to 5% is required.

Requirements

• B.S., B.A., or M.S. in a related field with 8–12+ years of relevant experience or equivalent; alternatively, an A.A.S. in a related field with 15+ years of relevant experience or equivalent.
• Experience in several skills applicable to the functional area and aptitude for continued learning.
• Ability to comply with SOPs and regulatory requirements.
• Good knowledge of quality and regulatory concepts, principles, and procedures.
• Ability to train others effectively.
• Ability to work on moderately complex problems and apply practical problem-solving methods with minimal supervision.
• Ability to follow detailed, specific instructions to complete assignments.
• Mastery of basic Quality business unit tasks applicable to the role.
• Strong computer skills, including familiarity with ERP, EDMS, Microsoft Word, PowerPoint, and Excel.
• Ability to take direction from experienced team members and contribute in a team environment.
• Good problem-solving skills and attention to detail.
• Ability to repeat and follow detailed scientific procedures with supervision.
• Ability to present results clearly in group meetings and written progress reports.
• Good interpersonal, written, and verbal communication skills, and willingness to ask questions about procedures and concepts.
• Aptitude and willingness to gain skills and knowledge in support of GMP regulations.
• Ability to meet the physical demands of the role, including using hands and arms, talking and hearing, frequently standing, walking, and sitting, occasionally climbing or balancing, and lifting or moving up to 50 pounds occasionally.
• Ability to wear appropriate personal protective equipment, which may include safety eyewear, respirators or breathing apparatus, lab coats, and gloves.
• Willingness to travel up to 5%.

Nice To Haves

• Relevant GMP experience preferred.

Responsibilities

• Perform quality review of complex documents, all types of data, protocols, and reports.
• Support quality floor audits and inspections.
• Support client and regulatory agency audits and inspections as needed.
• Understand customer needs and advocate for the client within the business unit.
• Identify deficiencies requiring action and support customer decision-making.
• Maintain quality databases and perform analysis and trending as needed.
• Assist with quality improvement initiatives.
• Identify and report issues in a timely manner.
• Develop quality SOPs, other quality documents, and reports as needed.
• Provide consultation on complex quality and compliance topics within areas of expertise.
• Develop and provide training on quality and compliance topics within areas of expertise.
• Understand Quality Management Systems, including investigations, corrective actions, and change control.
• Perform varied complex duties accurately, competently, and on schedule.
• Maintain accurate files and records.
• Complete required company training on time and comply with cGMP and other relevant training requirements.
• Respond to inquiries in a timely manner.
• Conduct routine assignments independently with support.
• Master basic Quality business unit tasks applicable to the role and exercise independent signature authority for those competencies.
• Train others effectively.
• Perform other duties as assigned.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior