Data and Document Reviewer

About the role

Almac is an exceptional, award winning, drug development solutions provider at the forefront of the pharmaceutical industry. We are a privately owned organization that has organically grown over 50 years now employing 6,000 highly skilled personnel worldwide. Our US Headquarters is located at Souderton, PA with additional operations scattered around the US and Europe. ‘Partnering to Advance Human Health’ is more than just a tagline – it is our way of life. Embracing diversity is at the heart of enhancing Almac Group’s unique culture and reflects our fundamental belief that all people deserve equality, inclusivity and the opportunity for advancement. We are committed to cultivating a welcoming, supportive, and inclusive environment for all. Together, we will build on the strength in our diversity and deliver exceptional solutions to advance human health globally.

Responsibilities

• Ensuring all raw data and associated documentation generated in the laboratory has been completed accurately and in-line with Almac Sciences procedures and the culture of Right-First-Time.
• Providing training to team members as part of the on-boarding process as well as on-going training and updates to the staff.
• Assisting management in fostering a culture of continuous quality improvement.

Qualifications

Education: Bachelor of Science Degree in chemistry or related field required.

• A minimum of five (5) years of practical experience of a wide range of analytical techniques and associated commercial data capture systems.
• A minimum of three (3) years' experience in the preparation and review of analytical protocols, reports and data in a GMP/GLP environment.
• Knowledge of a Quality System involving generation or review of analytical documentation and cGMP.

Preferred:

• Advanced degree level qualification in an Analytical related discipline.
• Previous experience in the design and delivery of training packages in support of business improvement.
• Prior experience with Regulatory Authorities.

Benefits

• Medical, Vision & Dental benefits from the 1st of the month following start date.
• 20 days PTO per year, accrued monthly following start date.
• 12 holidays per year.
• Company paid Long and Short-term disability along with Life Insurance.
• 401k company contribution.
• Professional development programs/ continuous learning opportunities.