Senior Specialist

Innova Solutions is immediately hiring for a Senior Specialist, Quality Systems

Position type: Full-time Contract to Hire
Duration: 6 months contract to hire
Location: Remote

As a Senior Specialist, Quality Systems you will:

Job Description

We are seeking a Senior Specialist, Quality Systems to provide quality expertise to support our Quality's team for the development and commercialization of our products in compliance with relevant US, EU and ICH requirements. The Sr Specialist, Quality Systems role will support in the execution, development, and continuous improvement of the Document Control/Management and Training Program as we grow and mature organizationally. We are looking for a teammate that can partner with internal departments to support the Document Control (eDMS), Learning Management System (LMS), and Quality Management Systems (eQMS), and to implement process improvements to meet business and regulatory requirements.

Responsibilities

• Supports the day-to-day management of the Quality Systems department, including areas such as Document Control and Training.
• Assist with the development and implementation of controlled documents including, but not limited to: SOPs, Work Instructions, training materials, protocols, reports, templates, and reference guides.
• Maintain internal formatting standards and ensure all documentation is formatted accordingly. Formatting may include creating templates, fonts and style, pagination and numbering and any other activities required to achieve document requirements.
• Assist with the Quality training program including collaborating with department managers to develop training requirements and training plans.
• Create and maintain GxP training files and matrices.
• Participate in system validation activities, as required.
• Generate compliance metrics and prepare routine KPI reports.
• Assists in delivery, maintenance, and continuous improvement of GxP processes in eDMS, eLMS, and eQMS.
• Adhere to all cGMPs, compliance/regulatory mandates and quality requirements.
• Build and maintain relationships with other departments and establish a culture of engagement and transparency with Quality.
• Perform other duties, as assigned.

Qualifications

• Bachelor's degree in Computer Science, Life Science or related field or applicable experience.
• 4+ years in Quality Systems/Quality Assurance experience in the regulated life sciences industry.
• Experience in the use of validated computer systems for management of regulated documents and training, including electronic records and electronic signatures.
• Thorough knowledge of electronic Quality Management Systems, Learning Management Systems and Quality Documentation Systems, admin experience strongly desired.
• Experience with Dot Compliance, preferred.
• Experience developing improvements to electronic Quality Systems.
• Strong software proficiency with Microsoft Suite and other desktop applications.
• Ability to manage multiple projects in a dynamic environment with attention to detail.
• A well organized, self-motivated and independent work style with the ability to initiate and follow through on expected duties.
• Excellent written and verbal communication and collaboration skills with the ability to interact with all levels throughout the organization.

Qualified candidates should APPLY NOW for immediate consideration. Please hit APPLY to provide the required information, and we will be back in touch as soon as possible.
We are currently interviewing to fill this and other similar positions. If this role is not a fit for you, we do offer a referral bonus program for referrals that we successfully place with our clients, subject to program guidelines. ASK ME HOW.
Thank you.
Preeti Sehgal


PAY RANGE AND BENEFITS:
Pay Range : $45/hr (depending on experience)
Pay range offered to a successful candidate will be based on several factors, including the candidate's education, work experience, work location, specific job duties, certifications, etc.

Benefits: Innova Solutions offers benefits( based on eligibility) that include the following: Medical & pharmacy coverage, Dental/vision insurance, 401(k), Health saving account (HSA) and Flexible spending account (FSA), Life Insurance, Pet Insurance, Short term and Long term Disability, Accident & Critical illness coverage, Pre-paid legal & ID theft protection, Sick time, and other types of paid leaves (as required by law), Employee Assistance Program (EAP).

ABOUT INNOVA SOLUTIONS: Founded in 1998 and headquartered in Atlanta, Georgia, Innova Solutions employs approximately 50,000 professionals worldwide and reports an annual revenue approaching $3 Billion. Through our global delivery centers across North America, Asia, and Europe, we deliver strategic technology and business transformation solutions to our clients, enabling them to operate as leaders within their fields.

Recent Recognitions:

• One of Largest IT Consulting Staffing firms in the USA Recognized as by Staffing Industry Analysts (SIA 2022)
• ClearlyRated Client Diamond Award Winner (2020)
• One of the Largest Certified MBE Companies in the NMSDC Network (2022)
• Advanced Tier Services partner with AWS and Gold with MS

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Innova Solutions is an Equal Opportunity Employer and prohibits any kind of unlawful discrimination and harassment. Innova Solutions is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment on the basis of race, color, religion or belief, national origin, citizenship, social or ethnic origin, sex, age, physical or mental disability, veteran status, marital status, domestic partner status, sexual orientation, or any other status protected by the statutes, rules, and regulations in the locations where it operates. If you are an individual with a disability and need a reasonable accommodation to assist with your job search or application for employment, please contact us at
or
. Please indicate the specifics of the assistance needed. Innova Solutions encourages all interested and qualified candidates to apply for employment opportunities. Innova Solutions (HireGenics/Volt) does not discriminate against applicants based on citizenship status, immigration status, or national origin, in accordance with 8 U.S.C. 1324b.
The company will consider for employment qualified applicants with arrest and conviction records in a manner that complies with the San Francisco Fair Chance Ordinance, the Los Angeles Fair Chance Initiative for Hiring Ordinance, and other applicable laws.

Benefits: Innova Solutions offers benefits( based on eligibility) that include the following: Medical & pharmacy coverage, Dental/vision insurance, 401(k), Health saving account (HSA) and Flexible spending account (FSA), Life Insurance, Pet Insurance, Short term and Long term Disability, Accident & Critical illness coverage, Pre-paid legal & ID theft protection, Sick time, and other types of paid leaves (as required by law), Employee Assistance Program (EAP).

ABOUT INNOVA SOLUTIONS: Founded in 1998 and headquartered in Atlanta, Georgia, Innova Solutions employs approximately 50,000 professionals worldwide and reports an annual revenue approaching $3 Billion. Through our global delivery centers across North America, Asia, and Europe, we deliver strategic technology and business transformation solutions to our clients, enabling them to operate as leaders within their fields.

Recent Recognitions:

• One of Largest IT Consulting Staffing firms in the USA Recognized as by Staffing Industry Analysts (SIA 2022)
• ClearlyRated Client Diamond Award Winner (2020)
• One of the Largest Certified MBE Companies in the NMSDC Network (2022)
• Advanced Tier Services partner with AWS and Gold with MS

Innova Solutions is an Equal Opportunity Employer and prohibits any kind of unlawful discrimination and harassment. Innova Solutions is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment on the basis of race, color, religion or belief, national origin, citizenship, social or ethnic origin, sex, age, physical or mental disability, veteran status, marital status, domestic partner status, sexual orientation, or any other status protected by the statutes, rules, and regulations in the locations where it operates. If you are an individual with a disability and need a reasonable accommodation to assist with your job search or application for employment, please call
. Please indicate the specifics of the assistance needed. Innova Solutions encourages all interested and qualified candidates to apply for employment opportunities. Innova Solutions (HireGenics/Volt) does not discriminate against applicants based on citizenship status, immigration status, or national origin, in accordance with 8 U.S.C. 1324b.

The company will consider for employment qualified applicants with arrest and conviction records in a manner that complies with the San Francisco Fair Chance Ordinance, the Los Angeles Fair Chance Initiative for Hiring Ordinance, and other applicable laws.