Almac Group is currently seeking a Quality Control Inspector Grade 1 for our Durham, NC location. The Quality Control Inspector will inspect operational activities for compliance to cGMPs, Almac SOPs, and other written quality and customer standards.
**This position is on 2nd shift: 3:30pm to 12:00am**
** Shift will include 10% shift differential**
Responsibilities include but are not limited to:
- Inspect clinical labels prepared by Almac Label Control to ensure that labels are acceptable for use in accordance with GMPs, Almac SOPs, and customer requirements. Approve labels prior to issuance into packaging operations.
- Inspect incoming goods to ensure that clinical trial materials are acceptable for use in accordance with GMPs, Almac SOPs, and customer requirements. Reviews inspections and provides batch disposition on incoming goods.
- Inspect labelling and assembly operations to evaluate and monitor the quality of each batch independent from Production to ensure that operations are carried out in compliance with GMPs, Almac SOPs, and customer requirements.
- Inspect the processing of distribution orders, destined for a clinical site or depot, to ensure compliance with GMP/GDPs, Almac SOPs, distribution instructions, and customer requirements.
- Interacts with Quality, Operations, and Project Services personnel at any Almac site to report, address, and resolve quality issues.
- Sample clinical trial material and components in accordance with Almac SOPs to maintain product integrity, prevent cross-contamination, and ensure full traceability
- Review/ approve expiry updates as well as change lot status of clinical trial materials as requested and in accordance with Almac SOPs. This may require a review of lot status or expiry dates for CTM located at other Almac sites.
- Handle other tasks as delegated by QC Supervisor such as changing/reviewing temperature charts or checking clinical supplies scheduled for destruction.
Qualifications:
Required Experience / Education:
- High School Diploma/GED
- 6 + months experience in GMP manufacturing, packaging, and/or quality assurance/control or equivalent
Preferred Experience / Education:
- Associates or Bachelor's degree with science background
- GMP training and computer literacy preferred
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
- 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.
Almac provides reasonable accommodations to people with disabilities who need assistance completing the application process. Please email us at [email protected] to request assistance.
UK 
Wed, 2 Oct 2024 00:00:00 GMT