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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 accommodations 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 frequently 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 will be required to follow all safety protocols and wear appropriate personal protective equipment when necessary. Knowledge and Skills:
Additional Voluntary Benefits
The Document Control Specialist is responsible for managing and maintaining all the critical documents and records in compliance with regulatory requirements.
Duties and Responsibilities: - Manages and maintains all documentation related to manufacturing, quality control, Quality Assurance, and distribution of pharmaceutical products, including batch records, standard operating procedures, specifications, and other critical documents. This includes the management of both electronic and physical records
- Develops and maintains Document Control systems to ensure accuracy, completeness, and accessibility of all documentation
- Uses the electronic Quality Management System for controlled documentation approval, revision, and obsoletion
- Ensures the timely compilation and delivery of controlled document requests
- Responsible for converting documents into standardized format, ensuring compliance and consistency with documentation throughout the QMS
- Ensures compliance with all regulatory requirements, including FDA, cGMP, and other industry standards
- Supports internal and external audits as needed, including preparation of documentation and records for audits/regulatory inspections
- Trains employees on Document Control procedures, document change requests, and requirements
- Collaborates with cross-functional teams to ensure Document Control processes are efficient and effective
- Supports continuous improvement initiatives related to the Document Control process
- Assists with special projects as needed
- 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 accommodations 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 frequently 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 will be required to follow all safety protocols and 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.)
- 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
- 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
