Advanced Compounding Solutions (ACS) is a division of New England Life Care (NELC). NELC is the largest and fastest growing home infusion company in New England. NELC is organized as a hospital-cooperative and currently provides services to more than 55 hospitals in Massachusetts, New Hampshire and Maine. ACS is a specialty drug pharmacy compounding service which serves most of its member hospitals.
We provide a wide variety of commonly used compounded medications, in bulk packaging, at a competitive rate, and offer best in class quality, safety, and service standards. For more information, visit our website at www.nelifecare.org.
To keep pace with our growth, ACS is seeking a talented Quality Assurance Analytical Associate II. This is a full-time 40 hour per week, Monday – Friday 1st shift position.
Under the supervision and direction of the Quality Manager, the person in this position is responsible for performing the mentioned tasks following established standard operating (SOP) in compliance with current good manufacturing practices (cGMP). This includes production documentation, investigations, laboratory reports and other applicable documents.
Manage Out of Specification (OOS) Analytical Investigations (HPLC & pH)
Proactively respond to 3rd party lab notifications.
Work with third party lab ACS staff on OOS investigations
Lead ACS internal investigations
Review & assess 3rd party investigation reports.
Provide CAPA where applicable
Trend batches & OOSs
Perform Vendor Audits where applicable
Provide Vendor assessment
Maintain approved Vendor list
Update Vendor records such as certifications, licenses, etc.
Participate in internal audits, provide recommendations and write reports
Annual Product Review and Quality Management System (QMS) Review
Participate in yearly product and the QMS review
Participate in quality quarterly report
Perform pH testing
Trouble shoot pH issues
Approved pH data
Generate pH certificate of analysis
Perform QA final visual Inspection
Write and Edit SOPs
Efficient Data Review with attention to details
Review batch records & ConsortiEX electronic records
Review 3rd party lab certificate of analysis and upload certificates on ConsortiEX and ACS website
Review any other QC / QA data
Review quality reports such as and not limited to NCRs, OOSs, Change Control, Customer Complaints
Review EM data
Maintains QC Lab in a clean, organized and well stocked manner.
Self-starter, independent contributor but also a team player
Assists the pharmacist(s) and quality manager in obtaining data as a regular participant in the quality management program.
Assures that professional practice complies with state and federal (FDA) regulations including, but not limited to the security regulations and the corporate compliance program.
Performs other duties / projects as assigned by direct supervisor.
Bachelor’s Degree in Analytical Chemistry, Biotechnology or similar required.
4 years QC Analytical Chemistry.
2 years HPLC experience
2 years experience in a Good Manufacturing Practices.
Experience working in an FDA regulated environment.
About Advanced Compounding Solutions
Advanced Compounding Solutions (ACS) is a member owned cooperative division of NELC whose primary focus is patient safety while adding value to its owners. We provide a wide variety of commonly used compounded medications, in bulk packaging, at a competitive rate, and offer best in class quality, safety, and service standards. Our ownership structure allows us to offer our members many other value added benefits beyond just competitive pricing, such as:
*Transparency: Access to information, operations/outcomes
*Control: Input into program design, pricing, drug avail management & quality control
*Quality Management: Dedicated quality control team to better manage risk
*Equity: Equity growth through utilization, downstream revenue captured
At Advanced Compounding Solutions, we don’t just want to sell you compounded medication, we want to become your indispensable care partner and do our part to improve the health of the community while reducing overall cost of care.