Quality Assurance Officer

Location
New Jersey, USA
Posted
Oct 08, 2021
Hotbed
Pharm Country
Required Education
Bachelors Degree
Position Type
Full time

Bionical Emas is the only CRO to combine Clinical Development, Early Access Programs and Clinical Trial Supply, delivering a unique, seamless approach to bring life-changing medicines to patients around the world. With clients, staff and offices around the globe, we offer a varied and international experience. Our clients range from smaller biotech’s to large global pharmaceutical companies, all with different needs and expectations.  As a business, we have invested heavily in ensuring we have the systems, processes, and people, to deliver for the very varied requirements of our clients. The culture of Bionical Emas is friendly, flexible and supportive, where all staff are encouraged to grow, develop and exceed their expectations. Main Responsibilities

• Working alongside the Senior Quality Team with building, maintaining & constantly developing an appropriate QMS

• Key aspects involve management of Change Controls, Deviations & Complaints and implementing Corrective and Preventative Actions

• Work closely with our Clinical Trial Supply department to ensure quality standards are maintained in supplying global access to       medicines and ancillaries for use in clinical trials

• Work closely with our Early Access Program department to ensure quality standards are maintained when delivering lifesaving treatments to patients around the world

• Supporting Bionical Emas's training management system

• Work with the Quality team to ensure our global network of storage and distribution facilities maintain industry standards

• Support Bionical Emas's packaging and labelling operations

Key things we are looking for

• The successful applicant will hold a Scientific Bachelor’s Degree (ideally pharmacy, pharmaceutical sciences, chemistry, biology or related)

• An understanding of and experience in the pharmaceutical industry

• Credible & confident communicator (written and verbal) at all levels

• Commercially astute & highly customer focused

• Strong analytical & problem-solving ability

• Hands-on approach, with a ‘can do’ attitude

• Strong organisational skills; ability to prioritise, with good time management skills

• Good attention to detail & ability to work accurately in a busy, demanding environment

• Ability to work with commonly-used IT platforms and packages

• Strong team player

 

Make a difference 

At Bionical Emas, we are committed to supporting our clients and our staff, so that they can bring life-changing medicines to patients around the world. Join Bionical Emas on our mission to make a difference. 

Bionical Emas Inc. is committed to equal employment opportunities regardless of any protected characteristic including: race, color, genetic information, creed, national origin, religion, sex, affectional or sexual orientation, gender identity or expression, lawful alien status, ancestry, age, marital status, or protected veteran status and will not discriminate against anyone on the basis of a disability. We support an inclusive workplace where associates excel based on personal merit, qualifications, experience, ability, and job performance.