What are the responsibilities and job description for the Sr. Quality Assurance Specialist - QA Compliance position at ALMAC Group?
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.
Responsibilities include but are not limited to:
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
Qualifications:
Required Experience / Education:
HS Diploma/GED
Required Work Experience:
* 5 years in Pharmaceutical Quality (with HS Diploma)
* 3 Years in Pharmaceutical Quality (with Bachelors Degree)
Required Knowledge:
Good knowledge of the GMP requirements of the pharmaceutical industry
Preferred Education/ Experience:
Bachelors Degree
Experience with the generation, execution and review of quality documents in a commercial
pharmaceutical packaging facility.
Preferred Knowledge:
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
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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
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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.