About CAICAI is a 100% employee-owned company established in 1996 that has grown to more than 800 people worldwide. We provide commissioning, qualification, validation, start-up, project management and other consulting services associated with operational readiness to FDA regulated and other mission-critical industries. Meeting a Higher StandardOur approach is simple; we put the client’s interests first, we do not stop until it is right, and we will do whatever it takes to get there.As owners of CAI, we are committed to living our Foundational Principles, both professionally and personally:We act with integrity.We serve each other.We serve society.We work for our future. With employee ownership, one person’s success is everyone’s success; we work diligently to accomplish team goals. We place Team Before Self, demonstrate Respect for Others, and possess a Can-Do Attitude (our core values). That is how we have grown exponentially. BenefitsOur full-time positions offer competitive compensation and benefits which include: up to 15% retirement contribution, 24 days PTO and 5 sick days per year, health insurance at extremely low cost to employee, financial support for both internal and external professional education as well as 70% long term disability paid for by the company. CAI Quality Control Specialists will have an opportunity to work with recognized subject matter experts allowing YOU to be a key player in bringing lifesaving therapies to market. As part of our company culture, we invest in YOUR future, and commit to hands on certifications as well as professional training. Our collaborative culture ensures that our customers benefit from exemplary work across our entire range of professional services. Requirements include:Position Description: You will be supporting our client’s Quality Control or Manufacturing Sciences organization for the contribution to one or more laboratory-relevant projects. This may include responsibility for the following: Lead /execute projects which encompass qualification/re-qualification activities related to QC equipment qualification, computer system validation and other QC systems following cGMP requirements.Technical writing of SOPs for laboratory equipmentParticipate in / lead laboratory continuous improvement projectsParticipate in validation and technical transfer of analytical methodsEnvironmental monitoring program tasks and activitiesPerform and review complaints, deviation investigations, change controls and CAPAs. Establish working knowledge with regards to regulatory requirements for equipment qualifications and calibrationReview and approve production and analytical documentation accompanying the release of drug substance, drug product and packaged finished goods to ensure conformance to appropriate SOPs, GMP and regulatory requirements.Provide expert knowledge in one or more analytical techniques to assist laboratory and quality groups make informed decisions.Support regulatory inspections and partner with client on customer and internal audit programmesDetermine stability study requirements through review of Master Specifications and Submission Scope Draft stability study protocols (real time/accelerated) in accordance with Master Specifications and Filing StrategyParticipate in multiple client project teams as Quality Control representativePerform and assist in additional duties as directed by the client Position Requirements: BS or MS in a science field, or equivalent years’ experience2 years of experience in GxP laboratories (microbiological or analytical) as a technical, analyst, supervisor, and/or managerDemonstrated understanding of Good Laboratory Practices (GLP) and Good Documentation Practices (GDP)Excellent oral and written communication skills in English, including communication with site supervision and managementExcellent skill in leading teams to perform complex tasks under pressureExcellent problem-solving skillsCustomer-service focusedSelf-directed, self-motivation with a demonstrated record in project accountabilityAbility to work independently as well as a team member, in a dynamic, fast paced environment Demonstrated skill in:Pharmacopeial requirements such as USP, EP, JP and ICH.Theoretical understanding of laboratory operations, systems, and methods.Following methods, procedures, and protocols. Preferred experience:Analytical instrument qualification.Environmental Monitoring program development and execution.Experience in out of specification, out of trend, out of limits, or other technical investigation/deviation writing.Stability program method optimization experience is advantageous.Method/specification optimization experience is advantageousWorking knowledge of six sigma and Lean Tools/management systems. Other Requirements:Excellent oral and written communication skills in English/Fluent in EnglishAble to travel domestically and internationally as required Able to work (paid) overtime Able to work in the US without sponsorship now or any time in the futureMust have been vaccinated or willing to be vaccinated for COVID-19 prior to starting employment #LI-MR1We are an equal opportunity employer; we are proud to employ veterans and promote diversity and inclusion in our workplace. Diversity is a strength for our global company. We pledge that CAI will be operated in a way that is fair and equitable to all – our employees, our customers, and the broader society. This job description is not all inclusive and you may be asked to do other duties. CAI will also consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of the Fair Chance Act (FCA) / Fair Chance Ordinance (FCO).