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Title

Environmental Monitoring Associate II 

Category Quality Control  
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 in 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. We encourage our employees to continue their personal and professional development in various ways.

Your New Role At Societal:

We are looking for an Environmental Monitoring Associate II. In this role, you will be supporting the Microbiology department with all routine and non-routine Environmental Monitoring activities. This role will perform microbiological testing of pharmaceutical production rooms, purified water and water for injection, and documentation with quality compliance.

How You Will Make An Impact:

  • Perform routine and non-routine environmental monitoring (EM) of GMP manufacturing facilities and early phase development suites for total non-viable particulates (NVP), viable Air particles (VA), viable surface (VS), Cleanroom Compressed Air (CCA), Cleanroom Compressed Gas (CCG).
  • Perform cleanroom operator qualification; manufacturing equipment validation/qualification; and aseptic production room qualification per ISO, USP, and GMP requirements.
  • Perform routine monitoring of Purified Water (PW) and Water for Injection (WFI) systems.
  • Take part in investigations of EM, PW, WFI, CCA, CCG excursions and assess any potential impact on product quality. Assist in trending EM, water system data and generate quarterly reports and yearly reports.
  • Document all testing results in accordance with quality standards and company procedures.
  • Maintain all related equipment and provide assistance, as needed, during equipment and facility qualification activities.
  • Interact closely with Microbiologists to ensure efficient, compliant, and timely execution all activities.
  • Provide assistance as needed to maintain the functioning of all assigned activities, including material ordering, inventory control, general housekeeping, and other microbiology duties.
  • Safely operate laboratory equipment in accordance with established practices.
  • Embodies Societal’s cultural values and aligns daily actions with department and company culture.
 
Position Requirements

   Ideal Candidate Will Bring:

  • High School Diploma or GED with Two (2) years of relevant experience in a pharmaceutical or related laboratory setting. Associate Degree in a scientific discipline with no prior experience
  • Preferred knowledge in environmental excursion investigations, root cause analysis, and/or knowledge of cleanroom practices.
  • Strong verbal and written communication skills, including technical writing.
  • Good interpersonal skills and ability to work effectively in a team environment and with client companies.
  • Demonstrates time management skills. Ability to react quickly to changes in project priorities and timelines and to support multiple projects simultaneously.
  • Working knowledge of Microsoft Office suite of software (Word, Excel, and Outlook)

Benefits:

For applicants based in California:

The California base pay rage for this position is estimated to be $21.00/hr.- $28.00/hr. The base pay offered may vary or fall outside of the range provided, depending on multiple individualized factors including but not limited to candidate’s job-related qualifications, internal equity, market data and geographic location.

At Societal, we offer a diverse and competitive total rewards package to attract and retain talent.  In addition to base compensation, all employees are eligible for one of our annual performance opportunities (bonus or commission) and equity-based long-term incentive. In addition, we offer a wide range of benefits including medical, dental, vision, paid time off, paid company shutdowns and holidays, 401k matching, life insurance, paid parental leave and much more.

Who is Societal:

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, GA.

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, and 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 EOE dedicated to a diverse workforce and a 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.

New hires will pass a background check and drug screen as a condition of employment.  
EOE Statement We are an EOE dedicated to a diverse workforce and a 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.  
EmpID None Specified 


This position is currently not accepting applications.

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