Clinical Systems Manager

Company: Innova
Location: Holly Springs
Posted on: February 1, 2025

Job Description:

Innova Solutions has a client that is immediately hiring for a Clinical Systems Manager.

Scroll down the page to see all associated job requirements, and any responsibilities successful candidates can expect.

Position type: Full-time - Contract
Duration: 12 Months
Location: Holly Springs, NC

As a Clinical Systems Manager, you will:

Description

Ideal candidate: Minimum of 12+ years of experience.

Job Details:
Develops, writes, edits, and formats materials such as Standard Operating Procedures, Business Practices, forms, checklists, technical manuals, installation guides, user manuals, and related technical protocols/reports and business process documentation.
When creating, updating and enhancing the documentation, adhere to format, content and style guidelines, considering usability and ensuring accuracy, consistency and quality.
Additionally, this position will be required to administer the processing of documents via the established Document Processing Review process. May require communication through a variety of media (e.g., CD, intranet, on-line training, etc.)


Qualifications
Extensive experience designing/writing protocols/reports for Method Validations, Verifications, Transfers, Material Qualifications, and Stability studies.
Core Analytical Competencies must include, but not limited to, HPLC/UPLC, HPIC, SEC (UV, CAD, ELSD, Fluorescence, Conductivity)K-F, TOC, ELISA, cell based assays, peptide mapping, glycan, aggregate and excipient analysis, and sample preparation techniques.
Create strong technically sound Standard Operating Procedures (SOPs), Operation and Maintenance (O&M) Procedures, Equipment Data Integrity Assessments, etc. required to support QC Laboratory Startup Process document changes within the electronic Quality Management System (eQMS) while ensuring good documentation practices (GDP) Manage document lifecycle updates to support QC Laboratory Readiness metric reporting Author Analytical Equipment Qualification Protocols (Performance Qualification Protocols) and Compendial Verifications to support ANC QC Laboratory Readiness as necessary Provide validation and change management support for Laboratory Equipment/Method Readiness.
Lead QC Quality Risk Assessments for Sample Chain of Custody and Analytical Testing -
Provide incident management support associated with nonconformances
Identify technical/operational gaps and propose solutions.


Three roles - the team is looking for three different specialties
1) Analytical validation & method
2) Both analytical validation & method experience and writing quality risk assessments (QRA's) for lab sample chain of custody.
3) Strong background in sample, stability, and reserve management. This person is going to assist in implementing the processes in place for the new site.

Ideally the candidate will have extensive diversified experience in commissioning of Quality Control (QC) Equipment supporting all QC laboratories, (Chemistry, Bioassay, Raw Material, and Microbiology). The candidate must have at least 15 years of functional experience and capable of leading technical documentation supporting Analytical Method Validation/Verification required to support GMP QC Laboratory readiness activities at the Client's North Carolina facility.


Skills: ; MS Office expertise ; previous technical writing experience ; regulated environment experience ; document version control experience ; excellent communication/writing skills

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!
Pradip Joshi
Email - Pradip.Joshi@innovasolutions.com
Phone: 213-401-2633

PAY RANGE AND BENEFITS:

Pay Range*: $65- $70/Hr

*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:
Named One of America's Best Employers for New Grads by Forbes (2024
Named One of the Best Companies to Work For by U.S. News & World Report (Private Companies List, 2024-2025)
One of the Largest IT Staffing Firms in the US - Ranked #3 by Staffing Industry Analysts (SIA, 2024)
One of the Largest Staffing Firms in the US - Ranked #13 by Staffing Industry Analysts (SIA, 2024; includes Innova Solutions, Volt, & HireGenics)
Named One of the Top Ten Private Companies in Atlanta by the Atlanta Business Chronicle (2023)
One of the Largest Certified Minority Business Enterprises (MBEs) in the United States (NMSDC, 2024)
AWS Advanced Tier Services Partner with 100+ certifications


Website: https://www.innovasolutions.com/

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 hr@innovasolutions.com or (770) 493-5588. 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.


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Keywords: Innova, Burlington , Clinical Systems Manager, Executive , Holly Springs, North Carolina