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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 hear. 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 occasionally required to stand, walk, reach with arms and hands, climb or balance, and to stoop, kneel, crouch or crawl. Vision abilities required by this job include close vision. Employee must be able to stand and walk for extended periods of time for consecutive days. Employee must be able to lift up to 30 lbs. Knowledge and Skills:
Key Competencies
Additional Voluntary Benefits
The Quality Assurance Specialist supports in oversight and performance of functional areas, and training in regards to processes, documentation as they pertain to quality standards and governmental regulations. This individual is primarily responsible for the day to day operations within the Quality Assurance department, ensuring the company and its departments are following established protocols, completing required documentation and reviewing and/or verifying finished product specifications are being met.
Duties and Responsibilities: - Follows, assists, and collaborates with the Quality Assurance Supervisor in all matters.
- Ensures company is following established Standard Operating Procedures (SOP) and track data relevant to the company’s Quality Management System (QMS), including but not limited to product lot information, 3rd party test results and errors found in various areas of operations.
- Follows all regulatory, cGMP and USP guidelines as required by job function.
- Works in accordance with QA Supervisor to provide Quality Assurance oversight where the business is responsible for adhering to current Good Manufacturing Practices (cGMP) including warehouse, manufacturing processes, inspection, labeling and packaging, batch record review, batch disposition and product distribution as applicable.
- Ensures all work is performed and documented in a timely manner and according to approved SOP and in general compliance with cGMP.
- Demonstrates a high level of discretion in the timely identification and resolution of events potentially impacting the quality of products and processes.
- Provides an established technical expertise for current processes and oversee training of department personnel on new processes.
- Maintenance of retained sample storage.
- Performs and review routine manufacturing, environmental monitoring and quality control data for in-process and finished products.
- Collects required information for any batch production records.
- Samples, inspects and controls product label inventory.
- Follows and encourages safety and appropriate regulatory guidelines.
- Completes other projects and duties as required and/or 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 hear. 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 occasionally required to stand, walk, reach with arms and hands, climb or balance, and to stoop, kneel, crouch or crawl. Vision abilities required by this job include close vision. Employee must be able to stand and walk for extended periods of time for consecutive days. Employee must be able to lift up to 30 lbs.
- Strong Microsoft Word and Excel skills.
- Demonstrated understanding of Quality Assurance in a regulated environment.
- Effective problem solving, strong communication (written and verbal) and organizational skills.
Key Competencies
- 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.
- Minimum 3 years of experience in Quality Assurance/Control Operations, or a related field in the healthcare industry.
- BS in science or a related field is desired.
- Minimum 2 years’ experience in Quality Assurance, Sterile Compounding and/or GMP production facility preferred.
- Minimum 2 years’ experience with FDA-regulated operations (cGMP processes) preferred.
- 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 4%: Invest in your future with our 401K plan, featuring a dollar-for-dollar match up to 4%.
- 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.
