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SalaryPosition Summary:
To perform this job successfully, an individual must be able to perform each essential function satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodation may be made to enable qualified individuals with disabilities to perform the essential functions.
While performing the responsibilities of the job, the employee is required to talk and listen. The employee is often required to remain in a stationary position for a significant amount of the workday and frequently use their hands and fingers to handle or feel in order to access, input, and retrieve information from the computer and other office productivity devices. The employee is regularly required to move about the office and around the corporate campus. The employee is regularly required to stand, walk, reach with arms and hands, climb or balance, and to stoop, kneel, crouch or crawl. The vision abilities required by this job include close vision. This position may require work in a laboratory or manufacturing environment, which may involve exposure to hazardous materials and chemicals. The employee must be able to wear appropriate personal protective equipment when necessary. Knowledge and Skills:
Additional Voluntary Benefits
The Supervisor, Quality Systems is responsible for ensuring adherence to regulatory standards, maintaining the integrity of controlled documents, and overseeing aspects of Quality Systems management. This role involves reviewing, updating, and managing various documents critical to regulatory and internal compliance.
Duties and Responsibilities: - Provides supervision to Document Control Specialist, directing, guiding, and supporting all daily activities
- Ensures the team's efficiency in managing controlled documents and adherence to internal and regulatory requirements
- Participates in internal and external audits, including preparation of documentation and records for audits/regulatory inspections
- Conducts thorough reviews of controlled documents for adherence to established standards, consistency, and clarity; identifies and resolves any conflicts or discrepancies in information
- Performs routine regulatory reviews to ensure compliance with applicable guidelines
- Identifies and facilitates updates to controlled documents to ensure the seamless implementation of changes while maintaining document integrity
- Prepares and submits bi-annual product submissions to regulatory bodies such as the FDA and state agencies
- Develops and maintains comprehensive product profile folders containing essential information related to product development, stability reports, and annual reports. Manages the entire product life cycle information within these profiles
- Develops and maintains master files to ensure readiness for audits, ensuring all necessary documentation is organized and readily accessible during regulatory inspections
- Monitors changes in regulatory guidance and stays informed about regulatory guidelines and updates to evaluate internal procedures and records
- Assists with special projects as needed
- Performs other duties as assigned
To perform this job successfully, an individual must be able to perform each essential function satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodation may be made to enable qualified individuals with disabilities to perform the essential functions.
While performing the responsibilities of the job, the employee is required to talk and listen. The employee is often required to remain in a stationary position for a significant amount of the workday and frequently use their hands and fingers to handle or feel in order to access, input, and retrieve information from the computer and other office productivity devices. The employee is regularly required to move about the office and around the corporate campus. The employee is regularly required to stand, walk, reach with arms and hands, climb or balance, and to stoop, kneel, crouch or crawl. The vision abilities required by this job include close vision. This position may require work in a laboratory or manufacturing environment, which may involve exposure to hazardous materials and chemicals. The employee must be able to wear appropriate personal protective equipment when necessary.
- Strong knowledge of FDA regulations, cGMP, and other industry standards
- Excellent organizational and time-management skills, with a high level of attention to detail
- Proficiency in document management software and Microsoft Office applications
- Ability to work independently and in a team environment, with excellent communication skills
- Ability to operate office machines (ex: fax machine, copier, etc.)
- Excellent interpersonal skills: ability to communicate effectively (orally and in writing) with all levels of management
- Customer Focus: Ability to build strong customer relationships and deliver customer centric solutions
- Optimizes Work Processes: Know the most effective and efficient processes to get things done, with a focus on continuous improvement
- Collaborates: Builds partnerships and works collaboratively with others to meet shared objectives
- Resourcefulness: Secures and deploys resources effectively and efficiently
- Manages Complexity: Makes sense of complex, high quality, and sometimes contradictory information to effectively solve problems
- Ensures Accountability: Holds self and others accountable to meet commitments and objectives
- Situational Adaptability: Adapts approach and demeanor in real time to match shifting demands of different situations
- Communicates Effectively: Develops and delivers multi-mode communications that convey a clear understanding of the unique needs of different audiences
- Bachelor’s degree in a relevant field or equivalent work experience, required
- Minimum of five years of experience in a document control role within a pharmaceutical manufacturing environment or equivalent experience
- No-Cost Medication: Get your prescribed compounded medications at no cost, ensuring your health without the financial burden
- Onsite Health & Wellness – IV Therapy Drips: Rejuvenate with complimentary onsite IV Therapy drips, enhancing your well-being and energy levels
- Comprehensive Medical, Dental, and Vision Options: Choose from three medical plans tailored to your needs, plus options for dental and vision coverage for you and your family
- Telehealth visits: Access board-certified Doctors anytime, anywhere for you and your family
- Paid & Volunteer Time Off: Enjoy paid time off for personal pursuits and contribute to causes you care about with volunteer time off
- Paid Holidays (8 scheduled; 2 floating): Celebrate with eight scheduled holidays and two floating holidays, giving you flexibility and time for personal traditions
- Life & AD&D Coverage: Secure your and your family's financial future with life and accidental death and dismemberment (AD&D) insurance
- FSA (Flexible Spending Account): Manage healthcare expenses smartly with pre-tax dollars in a Flexible Spending Account (FSA)
- 401K Dollar-for-Dollar Up to 3%: Invest in your future with our 401K plan, featuring a dollar-for-dollar match up to 3%
- Company Paid Long-Term Disability: Provided at no cost, which replaces 60% of your income if you become disabled for a long period of time
- Flexible Schedules: Balance work and life seamlessly with our flexible scheduling options
- Rewards & Recognition Program: Your hard work doesn't go unnoticed – enjoy rewards and recognition beyond your paycheck
Additional Voluntary Benefits
- Accident Insurance: Pays a lump sum benefit to help cover expenses following an accidental injury
- Hospital Indemnity Insurance: Enhance your peace of mind with supplemental hospital insurance for unexpected stays
- Critical Illness: Protect your finances from the expenses of a serious health issue
- Short-Term Disability: Protect your income during illness or injury with short-term disability coverage
- Supplemental Life & AD&D: Add an extra layer of financial protection for you and your loved ones with supplemental life and AD&D coverage
- Legal Services: Access professional legal assistance to address concerns confidently
- Identity Theft Protection: Safeguard your identity and finances with our identity theft protection benefit
- Pet Insurance: Care for your furry family members with our pet insurance coverage
- Employee Assistance Program: Confidential counseling and support services for a holistic approach to your well-being
