What are the responsibilities and job description for the Senior Specialist, Quality Assurance position at USPL NUTRITIONALS LLC?
Job Description
Date
12/2024
Location
1300 Airport Road, North Brunswick NJ
Title
Senior Specialist, Quality Assurance - Operational Support Technical
Department
Quality Assurance
Reports to
VP of QA
FLSA (Exempt or Non-Exempt
Exempt
Role Overview
The Senior Specialist, Quality Assurance – Operational Support Technical will be responsible for maintaining our Company’s compliance documentation by supporting Document Control or Records Management by aiming to improve document integrity, writing and communication. Using a thorough understanding of the company and the interdependencies of aspects of the business, the Specialist will help execute strategies and programs, as well as help create, develop, and implement tools, solutions, and initiatives. The Specialist will work on both daily tasks and project tasks, and work with management to assess and improve documentation and processes.
This position will help ensure compliance with SOPs, GMP documentation and 21 CFR Part 111 and 117.
This position Reports to the VP of QA.
Areas of Responsibility
- Preparation, Review and tracking management of different types of stability samples
- Review and/ or Preparation of different types of Stability protocols and stability reports
- Management of stability study program
- Review of different types of validation and /or verification documents for process, cleaning .
- Provide guidance, mentoring and training to Document Control or Records Management staff and user departments in proper use of the document/record management systems.
- Develop and oversee the creation of tools, resources, and programs to improve document/record quality and promote good writing.
- Coordinate review and revision of controlled documents.
- Collaborate with cross – functional teams including quality control, production , engineering , supply chain and customer service , to identify and resolve quality issues
- Manage internal and external audits, ensuring that findings are addressed, and corrective actions are implemented in a timely manner
- Assist with leading initiatives that broaden the impact of the group and help improve writing, document integrity and communication across the sites.
- Prepare /Review/approve changes in accordance with SOPs.
- Create documentation that meets the regulatory requirements before distributing to USPL users or customers.
- Plays an active role in the Company’s quality management team.
- Other duties as assigned.
Other Responsibilities Including Safety:
- Comply with all job-related safety and other training requirements.
Requirements
Education & Qualification:
- Bachelor’s Degree or higher in science or related scientific disciplines
- About 6--10 years of relevant technical work experience in Nutraceutical / Food/ pharmaceutical /biotech industry
- OR a combination of education and experience equivalent to the above requirements.
- Knowledge and compliance to GMP and GLP including 21 CFR Part 11, CFR Part 111 & 117.
- Hands-on experience with implementing and managing Quality Compliance systems and processes, experience in handling internal and external audits
- Strong leadership and interpersonal skills, problem solving skills, verbal and written communication skills, with the ability to identify and resolve quality issues
Certifications, Licenses, Credentials:
- N/A
Skills & Ability
- Demonstrate above average written communication skills in the English language.
- Advanced level user of Excel, Word and outlook and has excellent typing skills.
- effectively with department heads.
- Able to maintain a professional and positive attitude.
- Able to manage multiple tasks effectively & efficiently.
- Able to maintain confidentiality and possess a high level of ethics and integrity.
Physical Requirements (lifting, etc.):
- The employee is frequently required to sit (50%), stand, and walk (50%). Uses hands to finger, handle or feel writing tools and computer keyboard. May reach with hands and arms and infrequently may lift up to 30lbs. Use desk telephone/cell phone to talk and hear or converse with other employees.
Work Environment (Office, Warehouse, temperature extremes, etc.):
- Primarily located in an office environment where temperatures are controlled for heat and air conditioning; occasionally walks through warehouse or manufacturing workplace and will be required to wear appropriate PPE for each work area including safety shoes, hair net, safety glasses, face mask, gloves, or disposable jumpsuit.
The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. They are not intended to be an exhaustive list of all the job responsibilities, duties, skill, or working conditions. In addition, this document does not create an employment contract, implied or otherwise, other than an "at will" relationship.
Salary : $87,000 - $119,700
