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Operational Quality Manufacturing Specialist
Are you looking for an opportunity to support a Quality Management team in the day to day operations in a manufacturing environment? If so, this is the role for you.
As Operational Quality Specialist staff you will be responsible for supporting in implementing and maintaining an effective and robust quality management system. You will also perform day to day quality operations to ensure lean and efficient ways of working to meet compliance standards.
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:
* Perform quality oversight directly on the shop floor, guaranteeing that all the GMP standards are met during operations
* Execute and deliver quality objectives, quality improvement plan, and trends against the quality key performance indicators to drive continuous improvement
* Monitor quality performance and key performance indicators assigned to third parties to ensure quality and compliance issues are identified, communicated, and resolved
* Support the Quality Manager to ensure that an effective local product incident process is in place and manage any product quality related issues and train staff as appropriate
* Develop local processes to conduct root cause analysis; identify where corrective/preventative actions plans are required and ensure they are effectively implemented, monitored, and closed out
* Perform activities to support the risk management process to ensure effective management, timely reporting, review and escalation of quality risks
* Ensure all product specifications and related documents are maintained and compliant to current registered details
* Support the local change control process to ensure all planned major changes are effectively and compliantly managed
* Support the complaints management process to ensure potential issues are determine quickly, linked to the adverse events, reported, and follow up on product complaints
* Support Quality Manager in ensuring product storage and distribution performed by third party warehousing and distribution service providers complies with (COMPANY NAME) standards
* Ensure as appropriate documentation of batch records and retention of samples
Why you?
Basic Qualifications & Skills:
We are looking for professionals with these required skills to achieve our goals:
* Bachelor's degree in a science-related field
* Experience within the Pharmaceutical/Consumer Healthcare industries
* Experience in quality assurance systems particularly in the areas of batch manufacturing and release, product incidents and performing self-inspection
* Experience with regulatory requirements pertaining to good manufacturing practices and good documentation practices
* Experience working with effective quality documentation systems
Preferred Qualifications & Skills:
If you have the following characteristics, it would be a plus:
* Previous role as a quality associate or specialist for sterile manufacturing
* Excellent written and verbal communication skills
* Analytical thinker with good attention to detail and problem-solving skills in a structured process
* Team player with the ability to work in cross-functional teams
* Ability to work under pressure
* Identify areas of continuous improvement and innovative ways of working
* Ability to demonstrate flexible thinking
* Strong general computer literacy with Intermediate skills in Microsoft Word, Excel, Power Point and Outlook
Deadline for applications: March 25
Why Us?
(COMPANY NAME) is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030.
Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making (COMPANY NAME) a place where people can thrive. We want (COMPANY NAME) to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We're committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our (COMPANY NAME) leadership reflects our (COMPANY NAME) workforce.
If you require an accommodation or other assistance to apply for a job at (COMPANY NAME), please contact the (COMPANY NAME) Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).
(COMPANY NAME) is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.
Important notice to Employment businesses/ Agencies
(COMPANY NAME) does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact (COMPANY NAME)'s commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to (COMPANY NAME). The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and (COMPANY NAME). In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of (COMPANY NAME). (COMPANY NAME) shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.
Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, (COMPANY NAME) may be required to capture and report expenses (COMPANY NAME) incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure (COMPANY NAME)'s compliance to all federal and state US Transparency requirements. For more information, please visit (COMPANY NAME)'s Transparency Reporting For the Record site
