Aphena Pharma Solutions, Inc. · 2 days ago
Quality Assurance Supervisor
Easton, MD
Full-time
Onsite
Mid LevelAphena Pharma Solutions, Inc. is focused on quality in the pharmaceutical and medical device sectors, and they are seeking a Quality Assurance Supervisor. The role involves overseeing the quality assurance processes, ensuring compliance with regulations, and managing the QA Technician group to maintain operational efficiency and support business operations.
Health CareManufacturingMedicalPharmaceutical
Responsibilities
Record data and maintain accurate records per Current Good Documentation Practices (cGMP)
Assist with generating and approving controlled labels using programs provided
Approve lot information during generation of a work order
Assist with First piece approval (FPA) and In-process hourly inspection of finished good product according to document specifications
Assist with the operation of various equipment for Seal Integrity equipment
Asist with required in process retain, micro and analytical samples
Retrieval of documents using the EQMS computer system
Review all paperwork daily for accuracy and completeness
Assist in maintaining the quality management system compliance with Regulations
Ensure that the equipment is maintained and records kept
Assist and ensure nonconformances are initiated and reported promptly
Assist in the generation and resolution of corrective and preventive action plans
Ensure equipment is calibrated before use
Assist in maintaining the quality system
Troubleshoot quality concerns that may arise and report to QA Manager
Assist in incoming component, in-process products, and finished products inspection according to documented specifications
Retrieved documents from the EQMS system
Written and verbal communication skills are required to communicate issues and procedures among multiple departments
Read drawings, templates and other documents
Manage multiple product lines in a time-sensitive environment
As needed, work overtime, weekends, or alternate shifts
Assist in the development and writing of SOPs, Work Instructions, and Forms, as required
Qualification
Required
Knowledge of Current Good Manufacturing Practice (cGMP) Regulations pertaining to medical devices and pharmaceuticals
Manage daily activities of QA Technician group to ensure support for business operations
Train QA Technician personnel in all aspects of the quality duties to ensure compliance
Complete performance review and performance documentation for QA Technicians
Ensure paperwork is completed within a timing manner and complies with cGMP
Determine root cause and corrective and preventive action plan for any Investigations, CAPA, and OOS issues related to the area of responsibility and complete related documentation
Maintain operational efficiency and compliance with all test equipment and processes
Provide the necessary QA support needed for the rapid commercialization of new products and processes
Perform/assist in any required cGMP validations
Ensure the QA Technician are up to date on training to comply with the cGMP
Review in process batch records and equipment notebooks daily
Ability to work with Microsoft Excel, Word, and PowerPoint
Serve as backup for QA Technician when needed
Superior written and verbal communication skills are required to communicate issues and procedures among multiple departments
Ability to read and understand drawings, templates and other documents
Preferred
The ability to use the Following Equipment Is Desirable
Tensile Machine
Burst Test Machine
Torque Test Machine
Seal Integrity Machine
Company
Aphena Pharma Solutions, Inc.
Aphena Pharma Solutions is a large pharma solutions provider focused on contract packaging, repackaging and manufacturing for the pharmaceutical, OTC, dietary supplement, animal health and medical device marketplaces.
Founded in 2002
501-1000 employees
H1B Sponsorship
Aphena Pharma Solutions, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2021 (1)
Funding
Current Stage
Late StageTotal Funding
$14.65MKey Investors
Nexstar Financial
2014-03-07Debt Financing· $10M
2013-10-28Series Unknown· $1.07M
2013-03-20Series Unknown· $3.57M
Leadership Team
Eric L. Allen
Chief Executive Officer
Patrick G. Min
Chief Financial Officer
Company data provided by crunchbase