Data and Document Reviewer

ALMAC Group; Souderton (Montgomery County); On-site; USD 65,000 - 95,000; Full time

Benefits offered by this job

Medical

Vision & Dental

20 days PTO per year

12 holidays per year

Disability & Life Insurance

401k

Job summary

Almac Group in Souderton, PA, seeks a Data and Document Reviewer to ensure raw data and documentation are completed accurately in line with Almac Sciences procedures.

The role includes providing training to staff during onboarding and on-going updates, and supporting management in building a culture of continuous quality improvement within a GMP/GLP environment.

Qualifications

• 5+ years of practical experience with a wide range of analytical techniques and data capture systems.
• 3+ years of experience in preparation and review of analytical protocols, reports and data in GMP/GLP environments.
• Knowledge of a Quality System involving generation or review of analytical documentation and cGMP.

Responsibilities

• Ensure all raw data and associated documentation generated in the laboratory are completed accurately and in-line with Almac Sciences procedures and culture of Right-First-Time.
• Provide training to team members as part of on-boarding and ongoing training.
• Assist management in fostering a culture of continuous quality improvement.

Skills

Analytical techniques

Data capture systems

cGMP knowledge

Education

Bachelors of Science in Chemistry

Job description

Almac is seeking a Data and Document Reviewer for our Souderton, Pa. location. The Data and Document Reviewer is responsible for ensuring all raw data and associated documentation generated in the laboratory has been completed accurately and in-line with Almac Sciences procedures

Responsibilities includes but is not limited to:

• The Data Document Reviewer is responsible for ensuring all raw data and associated documentation generated in the laboratory has been completed accurately and in-line with Almac Sciences procedures and culture of Right-First-Time
• Provide training to team members as part of on-boarding process as well as on-going training and updates to the staff.
• Assist management in fostering a culture of continuous quality improvement.

Qualifications

Education:

• Bachelors of Science Degree in chemistry or related field required

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

What can Almac Group offer you?

• 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

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.

Almac Group, Inc. is an Equal Opportunity Employer - Minorities/Women/Protected Veterans/Disabled - Proudly embracing diversity in all of its expressions.

EEO is the Law

EEO is the Law GINA Supplement

Almac provides reasonable accommodations to people with disabilities who need assistance completing the application process. Please email us at [e-mail] to request assistance.