Sr. Quality Assurance Specialist - QA Compliance

Almac Group is currently seeking a Senior Quality Assurance Specialist- QA Compliance for our Audubon Palocation THE SENIOR QUALITY ASSURANCE SPECIALIST - QA COMPLIANCE IS RESPONSIBLE FOR MAINTENANCE OF THE ALMAC PHARMA SERVICES QUALITY MANAGEMENT SYSTEM AND ENSURING THAT OPERATIONS ARE CONDUCTED IN ACCORDANCE WITH CURRENT GOOD MANUFACTURINGPRACTICE.

Provide quality assurance support/advice and work closely with

operational departments to perform thorough RCA and ensure

investigations are complete and timely. This will involve interaction with

internal and external customers to achieve required timelines while

maintaining product quality and compliance.

Actively manage the implementation of Quality Management Systems

Initial review and assessment of deviation records

Review and approve Effectiveness Review plans and evaluations

Review completed change request actions and update records

Participate in Root Cause Investigations and CAPA actions

Log product complaints

Support site and global Quality Risk Management Program. Ensure

appropriate RCA is performed for investigations and appropriate CAPA

assigned. Perform review of the CAPA program for effectiveness

Liaison with clients to ensure quality expectations are met, including

attending client meetings as applicable.

Ensure Vendor queries and product complaints are managed in a timely

manner. Assist in the compilation of APRs, , SLA , and Risk Assessments,

as applicable Ensure materials and products are quarantined in a timely

manner to support vendor queries and investigations as applicable

Collate and present the site quality system metrics to identify trends and

facilitate management review.

Review and perform internal audits per the Internal Audit Schedule to drive

continuous improvement. Support and as applicable, lead client audits

and support regulatory inspections to ensure GMP compliance and assist

in customer and regulator audits, as appropriate

Review and where applicable approve GMP documents (such as Change

Controls, Effectiveness' reviews, etc.) within Pharma Services and assist in

training as required on new/ revised procedures

Required Experience / Education:

HS Diploma/GED

* 5 years in Pharmaceutical Quality (with HS Diploma)

* 3 Years in Pharmaceutical Quality (with Bachelors Degree)

Good knowledge of the GMP requirements of the pharmaceutical industry

Bachelors Degree

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

pharmaceutical packaging facility.

Knowledge of the regulatory requirements and industry standards for pharmaceutical packaging

processes

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

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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.