QA Specialist – Risk management
- United States
- Contract
- Compliance / Quality Assurance
Are you looking for the opportunity to work with a global biopharmaceutical company? This is your chance! Our client develops and delivers life changing medicines to millions of people globally and as part of their growth, they are looking for a QA Specialist to help support operations at their Maryland facility.
With their Drug Substance (DS) manufacturing network growing rapidly, they are committed to growing their portfolio of commercial biologics products supplied worldwide – and this is your opportunity to be involved!
Responsibilities will include:
- Creation, development and maintenance of Quality Management System procedures and training materials pertaining to the Quality/GDP area
- Handling of Product Quality Complaints, including e.g., internal reporting and responding to external customers
- Handling of tasks related to deviations, CAPAs, recalls, destructions, returns, risk management, self-inspections and change control
- Oversight of distributors and outsourced activities
- Support in the completion of Rpi checks
- Support with the development and maintenance of the local Quality training program
- Performing internal/external trainings of personnel
- Maintaining the subsidiaries in a state of inspection readiness
- Support with management of audits and inspections of the local office
- Completion of a university or other higher education course of study in pharmacy, chemistry, biology, or a related life science preferred
- Experience from a Quality Assurance position in the pharmaceutical industry (at a minimum eight years)
- Strong leadership skills and ability to lead your own work
- Good communication and organization skills
- Strong computer skills
- An understanding of the principles and guidelines of GDP, and personal knowledge of the relevant provisions of all relevant laws, regulations and provisions concerning medicinal products for human use
- Fluency in English
- Ability to work in a team which spans across several countries
The candidate must have the rights to work in the location stated in the job advert.
Please note, Quanta part of QCS Staffing does not sponsor Visa applications.
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I have always received a highly professional & personable service from the team at Quanta. They listen carefully to the specific requirements of available roles and work tirelessly to supply a pool of potential candidates and make the hiring and contract renewal process an easy activity to manage.
Global Pharmaceutical firm
Once again can I via you recognise the superb support I was given before, during and after this short contract. The support, was as usual professional and every friendly.
QA Specialist
We have worked together with Quanta for seven years now and have always received a professional service. Quanta’s speciality certainly lies within their technical sourcing abilities and they have met our demanding requirements time and time again. Coupled with this are the integrity of Quanta’s people and their ability to deliver.
Global Pharmaceutical firm
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