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Technical Operations Specialist

Avanir Pharmaceuticals

This is a Contract position in Aliso Viejo, CA posted June 12, 2019.

Technical Operations SpecialistThe position will be responsible for planning and overseeing of the Company’s product stability program at 3rd Parties, maintaining critical CMC databases in support of Regulatory filings, planning and coordinating clinical trial materials and preparing sections of CMC regulatory submissions.

This position will provide the operational and technical expertise required to manage product development, contract manufacturing, and analytical development activities for the Company’s pharmaceutical products and in support for departmental policies, procedures and projects.Essential Job Functions:Plans and executes drug product development activities between the Company and contract manufacturers for assigned projects to assure timely delivery of products for clinical studiesIdentifies technical or resource issues, and takes independent remedial action if needed to prevent delays in timelinesPrepare CMC Regulatory sections.Drive CMC regulatory activities including the planning and preparation of regulatory applications, documentation, and interactions with internal regulatory department to discuss issues and respond to queries as required.Assess and communicate CMC requirements to ensure all clinical activities follow applicable regulations and guidelinesAuthor and ensure compliance of Company SOPs, protocols, and specifications in order to codify procedures to be used as a reference among Company employees and contractorsParticipate in the investigation of non-compliance issues.

Provide recommendations for the corrective and preventive actions to bring operations into compliance.Conduct training to educate Company employees of the quality systems, process developments and improvements.Perform record review to assure quality submission of regulatory documents.Review product related documentation from CMOs and release drug product to distribution.This position require ability to travel up to 10 % of timeEducation/Qualifications:B.S.

Chemistry or related area preferred.

3 years of experience in the pharmaceutical development/manufacturing is requiredExperience with multiple aspects of the process development, analytical characterization, process scale-up, and/or regulatory registration of drug productsWorking knowledge of regulatory requirements for the drug development process and manufacturingExcellent communication and project management skills are required as this position is responsible for the scientific evaluation and coordination of work performed by external partnersAdvanced MS (Word, Excel, PowerPoint) skills – including use of Excel formulas and pivot tables; ability to create reports and manage data;Ability to work with multiple external and internal sources and stakeholders, balance priorities, provide concise and accurate analysis.Self-starter with strong attention to detail; strong interpersonal communication and writing skills.Demonstrated ability to interact and work with all levels of the organization and develop solid relationships.This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee.

Other duties, responsibilities and activities may change or be assigned at any time with or without notice.Physical Requirements:This position primarily works in an office environment.

It requires the ability to sit or stand for long periods of time and frequent walking.

Daily use of a computer, phone, office equipment and other computing and digital devices is required.

May be required to stand for extended periods when facilitating meetings or walking in the facilities.

Some local travel may be necessary, so the ability to travel by plane, operate a motor vehicle and maintain a valid Driver’s license and/or effectively navigate public transportation is required.

While performing the responsibilities of the job, the employee must be able to read and respond to interoffice communications as well as effectively participate in meetings.

The employee is often required to sit and use their hands and fingers, to lift up to 20 lbs., pull, push, carry, handle or feel.

The employee is required to carry, handle items, reach with arms and hands, to stoop, kneel, or crouch; talk or hear.

Mental demands may require prolonged concentration, reading comprehension, understanding and interpretation of concepts, ideas and philosophies.

The physical demands of the position described herein are essential functions of the job and employees must be able to successfully perform these tasks for extended periods.

Reasonable accommodations may be made for those individuals with real or perceived disabilities to perform the essential functions of the job described unless such accommodations would cause Avanir an undue burden.Work Environment:While performing the responsibilities of the job, these work environment characteristics are representative of the environment the job holder will encounter.

Reasonable accommodations may be made to enable people with disabilities to perform the essential functions of the job unless such accommodations would cause Avanir an undue burden.

While performing the duties of this job, the employee is occasionally exposed to moving carts, mechanical equipment (copiers, computers, coffee machines) and vehicles.

May be subject to smells and odors.

The noise level in the work environment is usually quiet to moderate.

The passage of employees through the work area is average and normal.EEO Statement:As an equal opportunity employer, Avanir Pharmaceuticals is committed to providing all applicants and employees with equal access to employment opportunities, regardless of sex, race, age, color, national origin, ancestry, disability, pregnancy, religion, genetic information, sexual orientation transgender status, gender identity, marital status, military or veteran status, or any other characteristic protected by federal, state, or local law.

All Avanir Pharmaceuticals employees, officers, principles, agents, and representatives are expressly prohibited from engaging in unlawful discrimination.

Consistent with federal, state, and local requirements, Avanir Pharmaceuticals will reasonably accommodate any qualified individual with a disability if such accommodation would allow the individual to perform the essential functions or the job, unless doing so would create an undue hardship.Avanir Pharmaceuticals shall abide by the requirements of 41 CFR-60-300.5(a) and 60-741.5(a).

These regulations prohibit discrimination against qualified individuals on the basis of protected veteran status or disability, and require affirmative action by covered prime contractors and subcontractors to employ and advance in employment qualified protected veterans and individuals with disabilities.Avanir Pharmaceuticals, Inc.

is a biopharmaceutical company focused on bringing innovative medicines to patients with central nervous system disorders of high unmet medical need.

As part of our commitment, we have extensively invested in our pipeline and are dedicated to advancing medicines that can substantially improve the lives of patients and their loved ones.

For more information about Avanir, please visit http://www.avanir.comAvanir is a subsidiary of Otsuka America, Inc.

(OAI), a holding company established in the U.S.

in 1989.

OAI is wholly owned by Otsuka Pharmaceutical Co., Ltd.

The Otsuka Group employs approximately 42,000 people globally, and its products are available in more than 80 countries worldwide.

Otsuka welcomes you to visit its global website at® is a trademark or registered trademark of Avanir Pharmaceuticals, Inc.

in the United States and other countries