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 Control Validation Associate II. This is a full-time 40 hour per week, Monday – Friday, 2nd 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 procedures (SOP) in compliance with current good manufacturing practices (cGMP). This includes production documentation, investigations, laboratory reports and other applicable documents.
Master Control Implementation-collaborate with master control team on software implementation and validation
Execute validations which include cleaning studies
Internal studies during CAPA implementation-growth promotion
Assist in writing & reviewing validation protocols
Any upcoming required validation
Perform Monthly, Quarterly and Yearly Trending
Assist in managing the EM program
Perform weekly, monthly, unscheduled EM of the ACS cleanroom
Read EM plates, submit recoveries for identification.
Initiate and participate in EM excursion investigations.
Trend EM data, Recoveries, MicroIDs and EM excursions
Maintain EM plates inventory
Manage EM equipment
Perform sterile gown qualifications
Efficiently Review Data and collaborate on reports
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 quarterly reports, NCRs, OOSs, Change Control, CAPAs, Incident Reports, Customer Complaints.
Collaborate with third party laboratory
Timely and correctly submit samples to labs
Proactively respond to 3rd party lab notifications.
Work with third party lab ACS staff on OOS investigations
Review & assess 3rd party investigation reports.
Assist with CAPAs where applicable
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
SOP writing and editing
Maintains QC Lab in a clean, organized and well stocked manner.
Leadership skills, to reinforce CGMP to the rest of the team where needed.
In the future to perform in house testing for sterility and endotoxin and actively participate in OOS investigations
Performs other duties / projects as assigned by direct supervisor.
Bachelor’s Degree in Biotechnology or similar required.
Required Experience/ Skills:
2-4 years’ experience in Validation (software, protocol writing and validation execution)
4-6 years’ experience in a Good Manufacturing environment
Knowledge of QC Microbiology experience
Sterile manufacturing and Environmental Monitoring
Excellent organizational skills
Ability to communicate effectively with all levels of personnel
Ability to explicitly follow instructions as set forth by SOPs.
Ability to work in the aseptic environment and demonstrate aseptic techniques.
Ability to recognize non conformances and follow NCR procedure for reporting.
Knowledge / practical experience with basic computer systems such as Microsoft Office (Word, Excel, Power Point, Outlook)
Dependability in attendance and job performance
Demonstrate ability to learn and take on responsibilities with minimal supervision
Preferred Experience/ Skills:
Experience working in an FDA regulated environment
About New England Life Care
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.