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1+ months

QC Investigator

Kelly Services
Windsor, CO 80551
**Quality Control Investigator**



Temp with a possible conversion to permanent



$29.00-$31.00 per hour



Day Shift



**Purpose and Scope**



The Quality Control Investigator is a technical leader within the QC functional area with a primary role in investigating sample failures and deviations from procedures. The role is intended for a person with significant industrial experience who will contribute specific compliance knowledge and investigation skills to the QC group.



**Essential Duties & Responsibilities**




+ Assume a high level, in-depth compliance leadership role in the QC laboratory for other analysts and peers. Such a role may entail training and mentoring of new hires, dissemination of specific knowledge to the QC group and technical leadership in specific projects as assigned.

+ Conduct complex and challenging investigations and non-conformances that need a high level of expertise and in-depth knowledge in chemistry garnered from prior employment experience or academic training.

+ Act as a primary technical resource for lab investigations and be a point of contact for QC and external departments.




+ Resolve testing issues including Out of Specifications and investigations for commercial, stability and developmental samples, as assigned by management.

+ Provide scientific recommendations for CAPA and effectiveness reviews in the QC department.

+ Own CAPA implementation and resolution and effectiveness checks.

+ Make scientific recommendations to management and other departments regarding Quality Control laboratory protocols and test procedures.

+ Assist laboratory management in trending quality events.

+ Assist the departmental leadership in new endeavors including efficiency efforts, organizational tasks, and non-routine activities that require a higher level of scientific skills.

+ Upon delegation assume a supporting role to the management team for activities such as the issuance of COAs, review of Change Controls, test methods and specification PCOs and participate in project meetings.

+ Provide support to the QC department for the evaluation and implementation of new technological innovations in laboratory automation systems, documentation systems and other technologies.

+ Accountable for maintaining a positive atmosphere of teamwork, camaraderie and respect towards co-workers.

+ Participate in required annual hazardous waste training.

+ Hazardous waste involvement may include but is not limited to container and tank management and inspections, generation of hazardous waste as a part of production or sampling processes, and transfer of hazardous waste between lab procedure area, satellite accumulation, and storage.

+ Respond to spills per CP 030-0202 Chemical Spill Response.

+ Perform various other duties as assigned.



**Knowledge, Skills & Abilities**




+ Strong grasp of root cause analysis and 5 Whys methodology.

+ Understanding of ALCOA+ and data integrity principles.

+ Effective communication and exceptional documentation and writing skills.

+ Proven ability in cross functional groups to problem solve, gain consensus, and drive effective improvement.

+ A demonstrated knowledge of fundamental chemistry pertaining to specific products and assays conducted in the Company QC laboratory.

+ Ability to grasp and enhance the technical expertise required for new products in the pipeline in order to support QC functions as per business needs.

+ High level of proficiency in Quality Control laboratory procedures and testing techniques.

+ Hands-on, operational and troubleshooting knowledge of analytical instrumentation within the QC department.

+ Ability to evaluate and adapt new technologies that are to be introduced to the department based on business needs.

+ Proficient knowledge of cGMP practices, regulatory and ICH guidelines.

+ An excellent grasp on USP and other compendial methods.

+ Knowledge of computer applications, including Microsoft Office.

+ Experience in authoring technical reports.

+ Excellent oral and written communication skills demonstrated through interactions internally and externally.

+ Ability to manage multiple projects concurrently and under tight time constraints.



**Education** **& Experience**




+ BS, MS or PhD in Chemistry, Biochemistry, Pharmaceutical Sciences or related field.

+ Pharmaceutical cGMP laboratory work experience combined with BS: **7** or more years; Masters: **5** or more years or PhD: **2** or more years.

+ Experience in the pharmaceutical industry to include experience with cGMP analytical testing of drug substances (DS) and Drug products (DP), preferably in high-volume Quality Control laboratory.






**Why Kelly** **** **?**



Kelly Science is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.


**About Kelly** ****



At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. at https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm
Posted: 2020-04-20 Expires: 2020-06-20

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QC Investigator

Kelly Services
Windsor, CO 80551

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