AMIVAS (US) LLC

Would you like to be part of a company that has the innovation, and capability to improve and save patient lives across the globe?
Amivas Inc. is an Australian, Canadian, and US joint venture focused on the development, manufacturing, and commercialization of therapeutics for the treatment of infectious diseases.
Amivas Inc. was formed in response to the urgent need for a US -based firm to assume responsibility for the manufacture and distribution of Artesunate for Injection, for severe malaria after quinidine gluconate was discontinued by the manufacturer.

ABOUT YOU:

Amivas is looking for a talented individual that can drive our electronic Quality Management System and monitor its effectiveness.

QUALIFICATIONS AND EXPERIENCE:

• Bachelor’s degree in Biology, Chemistry, Engineering or related field with 5+ years’ experience working in a cGMP environment (Pharmaceutical / Biotech / Device industry). A combination of education and experience will be considered.
• 3+ years’ experience working with electronic Quality Management Systems in a Quality Assurance capacity
• Strong knowledge foundation of FDA and EMA regulations regarding the manufacture of biologics or small molecule (21CFR 210, 211, Part 11, 820, 610, EU GDP and EU GMP Eudralex Volume 4 including Annex 1)
• Experience hosting and interacting with investigators from Regulatory Health Authorities
• PC literacy required; MSOffice skills (Outlook, Excel, Word, SharePoint and PowerPoint)

Skills/Abilities/Behaviors:

• Strong problem-solving skills regarding challenges along with effective decision making and implementation of solutions
• Strong interpersonal skills and integrity to promote relationships based on trust with customers, suppliers and co-workers
• Ability to manage multiple projects and changing priorities; work extended hours, if necessary, make sound decisions under pressure, and work effectively in a team environment
• Comfortable working and managing time in a virtual environment
• Ability and willingness to travel, including international travel (up to 15%)

Work Location: Hybrid (Virtual and onsite) in Frederick, MD 21702
Job Types: Full-time, Permanent

Benefits:

• 401(k)
• Health insurance
• Paid time off

Location:

• Frederick, MD 21702 (Preferred)

Ability to Commute:

• Frederick, MD 21702 (Required)

Willingness to travel:

• 25% (Preferred)

Work Location: Hybrid remote in Frederick, MD 2170

In this role you will be responsible for supporting and managing the day-to-day inputs and outputs of the organizations Quality System to support Amivas products in the US, EU and Rest of the World markets. Experience working within electronic Quality Management Systems to drive compliance and success. This is a hybrid position. Candidates must live within commuting distance of our Frederick, Maryland office but will be permitted to work from home a few days per week at management’s discretion.

Key duties of this role will include the following:

• Manage review/routing of document workflows in Amivas’s electronic Quality Management System (eQMS) and serve as the local (US) system administrator
• Document and execute well written Nonconformance investigations, Complaint investigations and effective Corrective Action/ Preventative Action reports consistent with the expectations of Regulatory Health Authorities
• Perform routine trending activities (KPIs) for each element of the Amivas QS (including but not limited to Nonconformance Reports, Change Control Reports, Corrective/Preventative Actions, Product Quality Complaints) to ensure quality issues are identified, escalated and corrected in a timely fashion
• Lead/ develop presentations for use of the Amivas eQMS, Annual GMP Refresher Training and Inspection Readiness Training
• Improve/ author procedures and work instructions to support the Quality System
• Assist with Supplier Quality Management activities (Maintenance of the Supplier Audit Schedule, Suppler Questionnaires, Approved Supplier List)
• Assist the QA leadership as required during inspections by Regulatory Health Authorities
• Assist with assembly of slides and information for Management Review Meetings
• Lead/ participate in internal and external audits
• Other tasks as assigned