What are the responsibilities and job description for the Quality Operations Specialist position at Almac Group?
Almac Group is currently seeking a Quality Operations Specialist for our Audubon, Pa location. The Quality Operations Specialist is responsible for providing and ensuring quality in support to the onsite packaging and warehousing operations at the Audubon facility and ensuring that operations are conducted in accordance with current GxP’s.
Responsibilities include but are not limited to:
- Verify and ensure Critical Process Parameters/Equipment Set-up/Challenges prior to start-up of the equipment/operation.
- Verify and ensure inspections/AQLs are correctly set-up and executed by Production to established quality criteria for each batch.
- Review and approve ‘first off’ samples produced during setup of Packaging operations.
- Review and approve finished good sample inspection.
- Review in-process and executed batch records on the Production floor to ensure compliance with Master documentation and GxPs and to meet turnaround times.
Qualifications:
Required Experience / Education:
- Associate’s degree in a Scientific discipline
- 5 years in Pharmaceutical QA, QC or Operations (with associate’s degree)
- 3 Years in Pharmaceutical QA, QC or Operations (with bachelor’s degree)
Required Knowledge:
- Experience with Microsoft Office applications and quality management systems
- Demonstrated ability for effective communication, teamwork, and problem-solving skills
- Adequate emotional intelligence to handle a variety of situations professionally and in accordance with regulatory compliance
- Experience within a manufacturing, packaging, and laboratory environments and associated equipment
Preferred Experience / Education:
- Bachelor's Degree in a Scientific discipline
- 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 as well as one day for Annual Diversity Day
- Company paid Long and Short-term disability along with Life Insurance
- 401k company contribution
- 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 over 7,500 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.
Benefits:
Vacation & Paid Time Off, 401K Plan, Health Insurance