Our company has an exciting opportunity for an QA professional to join their Global Development Quality group as an Associate Quality Specialist based from our Central London office where you will work 1-2 days per week with the rest of the time remote.
This role will expose you to the full range of investigational medicinal products in the our company's development pipeline, from simple small molecules through to complex immunotherapy treatments, and a chance to make a real difference to patients receiving these lifesaving and life changing medicines.
As an Associate Quality Specialist, you will be responsible for the final review of clinical batch records to ensure compliance with GMP and conformance with regulatory filings. The compilation and approval of this data pack and presentation to the QP for final release is the core function of the role, and you will work closely with global functions supporting the clinical supply chain, as well as clinical manufacturing sites internally and externally around the world to help you achieve this. We are therefore looking for excellent communication skills, an ability to manage issue resolution, confidence to work with minimal supervision, and a keen eye for detail.
Primary activities include:
* Completes batch reviews to ensure compliance to SOPs, GMPs and applicable regulations.
* Review and approve production and analytical documentation accompanying the release of drug substance, drug product and packaged finished goods to ensure conformance to appropriate SOPs, GMP and regulatory requirements, including supporting QP certification.
* Actively communicate and collaborate with functional areas to develop a strong working relationship and understanding of roles and responsibilities. Utilise this network to help resolve comments and issues that arise during audit and review.
* Follows standard procedures and consults with manager/supervisor to ensure resolution of exceptions.
* Compiles data for reports and presentations, provides data interpretation draws conclusions.
* Carries out all assignments to the standards of compliance, efficiency, innovation, accuracy and safety in accordance with Company and regulatory requirements.
* Keeps abreast of cGMP requirements as described in applicable worldwide regulations.
* Any Additional activities as assigned by the manager/supervisor
Qualifications, Skills & Experience Required:
Ideally you should have existing experience in a QA or similar role in a GMP environment, however we would be just as interested in new science graduates (bachelors degree minimum) with the right attitude and a willingness to learn.
We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively for the common good. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status:
Regular
Job Description
Our company has an exciting opportunity for an QA professional to join their Global Development Quality group as an Associate Quality Specialist based from our Central London office where you will work 1-2 days per week with the rest of the time remote.
This role will expose you to the full range of investigational medicinal products in the our company's development pipeline, from simple small molecules through to complex immunotherapy treatments, and a chance to make a real difference to patients receiving these lifesaving and life changing medicines.
As an Associate Quality Specialist, you will be responsible for the final review of clinical batch records to ensure compliance with GMP and conformance with regulatory filings. The compilation and approval of this data pack and presentation to the QP for final release is the core function of the role, and you will work closely with global functions supporting the clinical supply chain, as well as clinical manufacturing sites internally and externally around the world to help you achieve this. We are therefore looking for excellent communication skills, an ability to manage issue resolution, confidence to work with minimal supervision, and a keen eye for detail.
Primary activities include:
* Completes batch reviews to ensure compliance to SOPs, GMPs and applicable regulations.
* Review and approve production and analytical documentation accompanying the release of drug substance, drug product and packaged finished goods to ensure conformance to appropriate SOPs, GMP and regulatory requirements, including supporting QP certification.
* Actively communicate and collaborate with functional areas to develop a strong working relationship and understanding of roles and responsibilities. Utilise this network to help resolve comments and issues that arise during audit and review.
* Follows standard procedures and consults with manager/supervisor to ensure resolution of exceptions.
* Compiles data for reports and presentations, provides data interpretation draws conclusions.
* Carries out all assignments to the standards of compliance, efficiency, innovation, accuracy and safety in accordance with Company and regulatory requirements.
* Keeps abreast of cGMP requirements as described in applicable worldwide regulations.
* Any Additional activities as assigned by the manager/supervisor
Qualifications, Skills & Experience Required:
Ideally you should have existing experience in a QA or similar role in a GMP environment, however we would be just as interested in new science graduates (bachelors degree minimum) with the right attitude and a willingness to learn.
We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively for the common good. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.
Current Employees apply HERE
Current Contingent Workers apply HERE
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status:
Regular
Relocation:
No relocation
VISA Sponsorship:
No
Travel Requirements:
10%
Flexible Work Arrangements:
Hybrid
Shift:
Not Indicated
Valid Driving License:
No
Hazardous Material(s):
N/A
About the company
Merck & Co., Inc.,
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