Specialist, Quality Assurance
7 days ago
Position Summary:
In the role of Quality Assurance Specialist at Empower, your commitment to excellence will be integral to our mission of producing innovative medications that improve the health and happiness of people.
You will ensure that our company adheres to established Standard Operating Procedures (SOP) and meticulously track data relevant to our Quality Management System (QMS).
Your diligence will help maintain the highest standards of quality and safety, vital for expanding access to quality, affordable medication.
As a key player in our Quality Assurance team, you will work closely with the QA Supervisor to provide essential oversight across various operations.
Your responsibilities will include ensuring compliance with current Good Manufacturing Practices (cGMP) in areas such as warehouse operations, manufacturing processes, inspection, labeling, and packaging.
You will review batch records, manage batch dispositions, and oversee product distribution, ensuring that all work is performed and documented according to approved SOPs and in compliance with cGMP guidelines.
Your role will also involve the maintenance of retention sample storage, performing and reviewing routine manufacturing, environmental monitoring, and quality control data for in-process and finished products.
You will manage master batch records, collect necessary information for production batch records, and oversee the sampling, inspection, and control of product label inventory.
Your technical expertise will be invaluable in maintaining our high standards and ensuring that all procedures encourage safety and adhere to regulatory guidelines.
Join us at Empower and be part of a team where your attention to detail and dedication to quality will make a significant impact.
Your role will be essential in helping us achieve our vision of delivering exceptional health and wellness medications, fostering a culture of innovation, quality, and service.
Be a part of a company that values people and is committed to making a difference in the lives of many.
Duties and Responsibilities:
Ensures the company is following established SOPs and tracks data relevant to the company's QMS, including but not limited to product lot information, and errors found in various areas of operations.
Works in accordance with QA Supervisor to provide quality assurance oversight where the business is responsible for adhering to 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.
Performs and reviews routine manufacturing, environmental monitoring and quality control data for in-process and finished products.
Issues and manages the organization of master batch records, also collects required information for any production batch record as required during the review.
Follows and encourages safety and appropriate regulatory guidelines.
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 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 hear.
The employee is often required to remain in a stationary position for a significant amount of the work day 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.Knowledge and Skills:
Excellent attention to detail.
Basic PC skills including MS Word and Excel.
Demonstrated understanding of quality assurance in a regulated environment.
Effective problem solving, strong communication (written and verbal) and organizational.
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 other accountable to meet commitment.
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.
Experience and Qualifications:
High school diploma or equivalent, required. Bachelor's degree in science or related field preferred.
2+ years of experience in Quality Assurance/Control Operations, or a related field in the healthcare industry, required.
Benefits:
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.
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