Sr. Quality Assurance Specialist - Product Quality

Almac Group is currently seeking a Senior Quality Assurance Specialist- Product Quality for our Audubon Pa location. Responsible for the maintenance of the Almac pharma services Quality Management System.Quality oversight of new product introduction and change throughout the product lifecycle, supporting product release and ensuring that operations ae conducted in accordance with current good manufacturig practice.

Review and approve product specific documentation, including Master

Batch Records against product specifications and as needed, Executed

batch records.

Support Product release, including review of executed batch records as

applicable and validation reports and other supporting documentation to

ensure that all information contained within, is correct and accurate and

provided to meet project timelines.

Provide quality assurance support/advice to operational departments in

support of new and existing projects and products. This will involve

interaction with internal and external customers to achieve required

timelines while maintaining product quality and compliance.

Attend client project meetings and liason with clients to ensure quality

expectations are met, including attending client meetings.

Coordinate with internal and external stakeholders to ensure deviations and

complaints related to batches are completed in a timely manner and act as

a liaison to communicate with clients and obtain resolution, as required.

Quarantine products to support vendor queries and investigations as applicable.

Assist in the compilation and review of APRs, and Risk Assessments.

Compile and coordinate approval of Technical Quality Agreements with

supplier and clients.

Carry out internal and external audits to ensure GMP compliance and assist

in customer and regulatory audits, as appropriate

Support and feed into the quality system metrics to identify trends and

facilitate management review.

Identify, write, review and approve and implement GMP documents such

as SOPs, Product and QC specifications and assist in training as required

on new/ revised procedures.

Review and approve Change Controls and ensure assigned actions

(CAPA, Change control actions, etc.) are completed per assigned timelines.

HS Diploma/GED

5 years in Pharmaceutical Quality (with HS Diploma)

3 Years in Pharmaceutical Quality (with Bachelor's Degree)

Bachelors Degree in related field

Experience with the generation, execution and review of quality documents in a commercial

pharmaceutical packaging facility

Knowledge of the GMP requirements of the pharmaceutical industry

Knowledge of the regulatory requirements and industry standards for pharmaceutical packaging

processes:

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

* Hybrid work available for applicable roles

* Professional development programs/ continuous learning opportunities

Want to see our latest job opportunities? Follow us on

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.