Quality Assurance Administrative Assistant

Almac Group is currently seeking a Quality Assurance Administrative Assistant for our Durham, NC location. The Quality Administration team is to carry out all administrative duties relating to the quality functions in accordance with Good Manufacturing Practice and relevant SOPs in line with user demand at any Almac site, ensuring all documentation completed by QA Administration is of a high standard and complies with Standard Operating Procedures and Good Manufacturing Practice Requirements

Maintain an accurate and secure document archiving system as follows:

Scan Almac and customer approved documentation to Content Suite in high

resolution and color where possible as soon as it becomes available in order to

maintain the legibility of the document throughout the lifecycle.

Archive key Quality documents such as Change Request documents, Quality

Incidents and Technical Queries in a timely manner. Reference and append

documentation as necessary and log onto the appropriate tracking systems.

Facilitate shipment of documentation to off-site long term storge, customers and

to other Almac Clinical Services sites

Administration of activities associated with the SOP updates:

Issue authorized copies

Retrieve and account for superseded SOPs.

Administration of activities associated with the PQS:

Allocate electronic document references where applicable

Logging of associated action items from Risk Assessments and Change

Controls

Issuance and reconciliation of logbooks

Assist the Client Audit Managers with administration activities in support of customer audits.

* High School diploma (or equivalent)

* 3+ years administrative experience (with HS Diploma)

* 2+ years administrative experience (with Associates Degree)

* 1+ years administrative experience (with bachelor's degree)

* Electronic archiving systems

* Microsoft Office

* Bachelor's Degree

* 1+ years working in quality assurance with a pharmaceutical company

* Knowledge of Current Good Manufacturing Practices (cGMP)

* GMP document control/lifecycle

* Working with Quality Systems

* 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

* Hybrid work available for applicable roles

* Professional development programs/ continuous learning opportunities

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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.

RECRUITMENT AGENCIES PLEASE NOTE: Almac will only accept applications from agencies/business partners that have been invited to work on this role through our portal. Candidate Resumes/CV's not submitted through our portal or directly to Hiring Managers will be considered unsolicited, and no fee will be payable. Thank you for your cooperation.

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 ADARequest@almacgroup.com to request assistance.