Position Summary:
At Empower, the Batch Record Reviewer plays a pivotal role in ensuring our products maintain the highest standards of quality, aligning with our vision of expanding access to quality, affordable medication.
In this dynamic role, you will be at the heart of our production processes, meticulously reviewing post-execution batch records across our various manufacturing streams, including Sterile and Solid Dose Manufacturing. Your keen eye for detail will ensure that all documentation aligns with cGMP standards, directly contributing to the quality of our products. Working closely with both Manufacturing and Quality personnel, you will facilitate seamless documentation corrections and maintain vital metrics that drive our commitment to excellence.
Your contributions will be essential in presenting key metrics and ensuring that all errors and corrections are resolved efficiently and in accordance with our SOP requirements. Your proactive approach to problem-solving and your dedication to quality will make you an integral part of our team.
If you are proactive, detail-oriented, passionate about making a difference and excited about the opportunity to work in a vibrant, forward-thinking environment, we invite you to join us at Empower. Together, we can create a healthier future and transform the pharmaceutical industry for the better.
Duties and Responsibilities:
- Completes post execution review of all Production batch records, including Sterile Manufacturing, Solid Dose Manufacturing, and Inspection and Labeling.
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Owns the Batch Record flow for in-process Production documentation.
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Coordinates intradepartmental documentation corrections with applicable Manufacturing personnel.
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Works closely with Quality personnel to incorporate clarifying information on cGMP documentation, as needed.
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Creates and maintains tools to track and communicate metrics surrounding the documentation performance by the team.
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Assists with the storage and organization of completed documentation for seamless retrieval.
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Presents monthly metrics surrounding Operations GDP performance.
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Assists in creation of red lined documents by providing error rate data to Manufacturing Specialists and departmental leadership.
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Performs the submission of non-conformances related to documentation errors found during the review process, as applicable.
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Assures all errors and corrections are resolved according to SOP requirements.
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Ensures adequate quantities of administrative supplies to support batch record completion activities.
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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 essential functions.
While performing the responsibilities of the job, the employee is required to talk and hear. The employee is often required to remain stationary for a significant amount of the workday and frequently use their hands and fingers to handle or feel to access, input, and retrieve information from the computer and other office productivity devices. The employee is required to stand for most of the duration of the shift (5 days/8 hours) and to move about the office and around the corporate campus. The employee must stand, walk, reach with arms and hands, climb or balance, and stoop, kneel, crouch, or crawl. Vision abilities required by this job include close vision, also the ability to lift 50 lbs. objects from the floor is required. The employee must be able to wear proper PPE, including but not limited to scrubs, hair net, beard cover, shoe cover, gloves, N-95 mask, safety glasses, lab gown, full body coverall, full-face and/or half-face respirators while performing their daily tasks in Non-Sterile Hazardous and Non-Hazardous Lab controlled environments.
Knowledge and Skills:
- Meticulous and self-motivated.
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Skills in Microsoft Word and Excel are required.
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Ability to collaborate effectively with a team to achieve goals around safety, quality, and delivery.
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Ability to carry out and/or deliver detailed written and oral instructions.
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Must be able to perform fundamental mathematical calculations.
Key Competencies
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Customer Focus: Ability to build strong customer relationships and deliver customer centric solutions.
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Optimizes Work Processes: Know the most effective and efficient processes to get things done, with a focus on continuous improvement.
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Collaborates: Builds partnerships and works collaboratively with others to meet shared objectives.
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Resourcefulness: Secures and deploys resources effectively and efficiently.
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Manages Complexity: Makes sense of complex, high-quality, and sometimes contradictory information to effectively solve problems.
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Ensures Accountability: Holds self and others accountable to meet commitment.
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Situational Adaptability: Adapts approach and demeanor in real time to match the shifting demands of different situations.
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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. Associate or bachelor’s degree preferred.
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3 -5 years previous manufacturing experience required.
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3-5 years previous cGMP experience required; LEAN manufacturing experience preferred.
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Experience in QA, Compliance, Auditing in a cGMP manufacturing environment is preferred.
Benefits:
- No-Cost Medication: Get your prescribed compounded medications at no cost, ensuring your health without the financial burden.
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Onsite Health & Wellness – IV Therapy Drips: Rejuvenate with complimentary onsite IV Therapy drips, enhancing your well-being and energy levels.
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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.
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Telehealth visits: Access board-certified Doctors anytime, anywhere for you and your family.
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Paid & Volunteer Time Off: Enjoy paid time off for personal pursuits and contribute to causes you care about with volunteer time off.
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Paid Holidays (8 scheduled; 2 floating): Celebrate with eight scheduled holidays and two floating holidays, giving you flexibility and time for personal traditions.
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Life & AD&D Coverage: Secure your and your family's financial future with life and accidental death and dismemberment (AD&D) insurance.
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FSA (Flexible Spending Account): Manage healthcare expenses smartly with pre-tax dollars in a Flexible Spending Account (FSA).
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401K Dollar-for-Dollar Up to 4%: Invest in your future with our 401K plan, featuring a dollar-for-dollar match up to 4%.
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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.
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Flexible Schedules: Balance work and life seamlessly with our flexible scheduling options.
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Rewards & Recognition Program: Your hard work doesn't go unnoticed – enjoy rewards and recognition beyond your paycheck.
Additional Voluntary Benefits
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Accident Insurance: Pays a lump sum benefit to help cover expenses following an accidental injury.
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Hospital Indemnity Insurance: Enhance your peace of mind with supplemental hospital insurance for unexpected stays.
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Critical Illness: Protect your finances from the expenses of a serious health issue.
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Short-Term Disability: Protect your income during illness or injury with short-term disability coverage.
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Supplemental Life & AD&D: Add an extra layer of financial protection for you and your loved ones with supplemental life and AD&D coverage.
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Legal Services: Access professional legal assistance to address concerns confidently.
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Identity Theft Protection: Safeguard your identity and finances with our identity theft protection benefit.
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Pet Insurance: Care for your furry family members with our pet insurance coverage.
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Employee Assistance Program: Confidential counseling and support services for a holistic approach to your well-being.