Share Email Opening Apply Now
Title

IT Lab Systems Analyst II  

Category Information Technology  
Description

Why Join Societal CDMO?

Mission and Culture:

Each day we Bring Science to Society as we work towards improving the quality of life for patients who benefit from the therapies that we manufacture. We strongly believe that every employee plays an impactful role in accomplishing our mission of improving patients lives through client partnerships. Whether you are working hands-on developing, manufacturing, or, testing the products or if you are utilizing your expertise in any other way, through your work here you will have an opportunity to positively affect countless lives.

We foster a culture that is diverse, inclusive, challenging,and supportive. At Societal, we are committed to continuous improvement both as individuals and as an organization and we encourage our employees to continue their personal and professional development in a variety of ways.

Benefits:

We offer a competitive total rewards package that includes health benefits, annual performance bonus, stock options, generous paid time off, holiday shutdowns, parental leave, matching 401k contributions and much more!

Your New Role At Societal:

We are looking for anIT Systems Analyst, Lab Systems. In this role you will be primarily providing IT support for GxP computerized laboratory systems across multiple sites.

You will also manage computer system implementation and validation projects including the development and execute of computer system validation (CSV) protocols and procedures.

And you will serve as a liaison between Information Technology and the user community, consistently delivering high-quality services to customers.

This role will be hybrid with onsite work in San Diego, CA and will support computerized systems at all sites.

How You Will Make An Impact:

Provide timely direct support and problem solving on the technical-based needs of end-users such as developing and revising operating procedures for system and performing system administration and maintenance activities, updates, and changes.

Developand reviewcomputer validation strategies including the development and review of computer validation documents such as user requirements specifications, validation plans, functional and design specifications, testing protocols, 21 CFR Part 11 assessments, risk assessments, and validation summary reports.

Leadcomputer system implementation and validation projects with the ability to manage multiple projects varying in complexity from the creation of work plans, identifying resource and budget needs through managing the project schedules, budgeting and leading project teams.

Buildrelationships with system owners and communicate business requirements back to IT management. Makerecommendations and implementimprovements with customer involvement.

Apply knowledge, experience and initiative in resolving highly complex non-standard problems and developing recommendations for solutions.

Recognize and take ownership when problems occur, make necessary decisions and escalate/delegate as necessary.

Influences, listens & values/recognizes all opinions and represents IT in a diplomatic way facilitating open discussion and collaboration across all functions

 
Position Requirements

Ideal Candidate Will Bring:

  • Bachelor’s degree (B. A., B. S.) in Computer Science, Information Systems, or related scientific discipline from four-year college or university. Significant relevant work experience may be substituted for degree requirements.
  • Generally, 2-5 years of related experience in similar role.
  • Experience in supporting lab systems in a GxP environment including the design, implementation, validation, and maintenance of computer systems in a GxP environment
  • Knowledge of computer system development lifecycle and computer system validation
  • Working knowledge of lab systems like LIMS, Chromatography data systems (HPLC/UPLC/GC/MS), Dissolution systems, stability sample management systems, FT-IR, TOC, particle size analyzers etc. (examples include Thermo Sample Manager, Waters Empower, Agilent Open Lab, H&A SLIM)
  • Excellent written and oral communication skills with English fluency including:
  • Establishing and implementing policies and procedures
  • Writing reports, business correspondence, presentations, validation documentation, procedures, training manuals, and other documents
  • Working knowledge of related IT systems and administration like Microsoft Windows Server and Active Directory technologies, Microsoft SQL and Oracle databases, Local and Wide Area Networks including their topologies, Microsoft Windows desktop and server operating systems, Windows Terminal Server, Citrix, and data backup utilities.
  • Experience with deploying and supporting cloud-based systems such as Amazon WorkSpaces is a plus.
  • Societal is a bi-coastal contract development and manufacturing organization (CDMO) with expertise to deliver on our client's needs, regardless of complexity level. These projects span pre-Investigational New Drug (IND) development to commercial manufacturing and packaging for a wide range of therapeutic dosage forms. We provide industry leading support for small molecule therapeutic development, end-to-end regulatory support, clinical and commercial manufacturing, aseptic fill/finish, lyophilization, packaging and logistics services to the global pharmaceutical market. We do all of this in our best-in-class facilities in San Diego, California and Gainesville, Georgia.
  • If you would like to apply for this position, please visit our website at www.societalcdmo.com and click on the "Careers" section.

 

New hires will pass a background check, drug screen, and will be required to show proof of COVID vaccination (subject to limited qualified exemptions) as a condition of employment.

We are an equal opportunity employer (EOE) dedicated to a diverse workforce and Drug Free work environment. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other characteristic protected by law.  If you require an accommodation to complete the application or interview process, please contact careers@societalcdmo.com.

 
About the Organization Societal is a bi-coastal contract development and manufacturing organization (CDMO) with expertise to deliver on our client's needs, regardless of complexity level. These projects span pre-Investigational New Drug (IND) development to commercial manufacturing and packaging for a wide range of therapeutic dosage forms. We provide industry leading support for small molecule therapeutic development, end-to-end regulatory support, clinical and commercial manufacturing, aseptic fill/finish, lyophilization, packaging and logistics services to the global pharmaceutical market. We do all of this in our best-in-class facilities in San Diego, California and Gainesville, Georgia.





If you would like to apply for this position, please visit our website at www.societalcdmo.com and click on the "Careers" section.




New hires will pass a background check, drug screen and will be required to show proof of COVID vaccination (subject to limited qualified exemptions) as a condition of employment.
 
EOE Statement We are an equal opportunity employer (EOE) dedicated to a diverse workforce and Drug Free work environment. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other characteristic protected by law.  
EmpID None Specified 

This position is currently accepting applications.

Apply Now



WE ALSO RECOMMEND

Other Jobs Within Same Category
-- None found --



Other Jobs Within 60 Miles
Purchasing Coordinator in San Diego, CA
Posted on: 10/18/2022
[Apply Now]

Director, Operations in San Diego, CA
Posted on: 10/28/2022
[Apply Now]

Environmental Monitoring Microbiology Associate II in San Diego, CA
Posted on: 10/12/2022
[Apply Now]

Project Manager-Hybrid in San Diego, CA
Posted on: 12/6/2022
[Apply Now]

Business Development Director in San Diego, CA
Posted on: 11/29/2022
[Apply Now]



 


 
Click here for technical assistance.