A-S Medication Solutions (formerly Allscripts Medications) is an FDA-licensed / VAWD-accredited pharmaceutical wholesaler and re-packager. We assist healthcare organizations, in a variety of specialties, set-up and operate onsite medication dispensaries in order to improve medication adherence, convenience to their patients as well as present a revenue stream or cost savings to the organization. In addition to providing highest-quality unit dose medications we also provide products and services such as dispensing software, billing services, and mail order to provide a complete end-to-end package for our clients. We are licensed in and have clients located in all 50 states. Due to the US healthcare landscape, we have experienced massive growth in the past few years because of our ability to provide much needed pharmacy products and services at the patient point-of-care at a cost savings. The Quality Associate is responsible for assuring that all pharmaceutical products released to finished goods for distribution have been produced and documented in accordance with cGMP and all applicable regulations, company polices, and standard operating procedures. Primary responsibilities include batch record review, reporting of process deviations, issuance of product holds, performing line startups, collecting environmental monitoring data, and documenting compliance audits. Quality Associates work closely with production personnel and management to ensure product quality and to help facilitate proper execution of production scheduling. Additional general responsibilities include management of retain samples, conducting training, qualification of production technicians, participation in quality investigations, developing new and revised procedures, and supporting continuous improvement initiatives.

Duties/Responsibilities:

Execute quality assurance batch record review to identify, document, and help resolve any process deviations, documentation errors, or product quality issues. Place suspect product on hold in quarantine areas and disposition in accordance with approved procedures. Perform routine QA activities including line start up, environmental monitoring, cleaning logs, compliance audits, retain sample collection, trending, and review of production log sheets. Participate in deviation and complaint investigations, root cause analysis, and implementation of corrective actions. Help build and revise SOPs and forms. Support continuous improvement projects and lean initiatives.

Requirements:

The successful candidate must possess the following skills: Strong technical knowledge of Production.

• 1-3 years minimum work experience in a cGMP related medical products industry, pharmacy, or clinical setting.
• Knowledge of FDA Current Good Manufacturing Practices for Finished Pharmaceuticals (21 CFR parts 210 and 211).
• Ability to prioritize multiple tasks to ensure compliance with regulations and standard operating procedures.
• Knowledge and application of computer systems/software used for word processing, spreadsheets, and databases.
• Ability to work with cross-functional teams and to interact effectively with peers, management and customers.
• Demonstrated critical thinking ability with a project management mindset.
• Ability to work independently, accept new assignments, and problem solve.

Education Required:

• High School Diploma Schedule Hours 7:15AM - 4:00 PM Monday through Friday.

Pay:

From $20.67 per hour Expected hours: 37.0 - 40.0 per week

Benefits:

Dental insurance Health insurance Life insurance Paid time off Vision insurance

Experience:

cGMP related: 1 year (Required)

Work Location:

In person