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20 days old

Quality Compliance Specialist

Kelly Services
Carlsbad, CA 92008
**If you are interested and meet the requirements of the role, please send your resume to Meredith.fortener@kellyscientific.com and reference job# 8447488.**


**Duration:** Monday to Friday - 8am to 5pm


**Location:** Carlsbad-CA


**Contract Length:** 12 Months


**Pay:** $39.66 Per Hour



**Job Summary**


At Microbial Material Services (MMS), a new Business Unit, we deliver from process development through commercial supply, the expertise and resources necessary to help clients deliver innovative plasmid-based therapeutics as critical raw materials, drug substances, and drug products. Placed in the forefront of our leading- and cutting-edge Cell and Gene Therapy businesses enabling clients to cure genetic, rare, and otherwise untreatable diseases as their CDMO of choice.


**How will you make an impact?**


+ Part of a cohesive team responsible for Deviations, CAPAs, and Process and Equipment related Change Controls for all phases of manufacturing.

+ The incumbent will also support equipment, documentation, investigations, and improvement initiatives within the manufacturing operations.

+ Works independently with minimal supervision and direction.

+ Performs work that consistently requires independent decision making and the exercise of independent judgment and discretion.


**What will you do?**


+ Support Manufacturing in batch record issuance and label issuance

+ Support Manufacturing with deviation investigation and deviation management

+ Interact with SMEs in all functional areas to manage their response to any findings and their timely commitment to address those findings within CAPA and other quality systems.

+ Support projects with cross-functional members independently while communicating to stakeholders and leadership team

+ Performs training with staff for Deviations, Change Controls, CAPAs, and other areas as needed

+ Support change controls if needed

+ Support corrective and preventative actions

+ Support internal and external observations

+ Support creation and review of written procedures such as standard operating procedures, work instructions and production batch records

+ Practices and promotes safe work habits and adheres to safety procedures and guidelines

+ Works cooperatively with others to meet group and organizational goals

+ Participates in initiatives to support innovation and continuous improvement activities and improved compliance with quality procedures, policies, and regulations.


**How will you get here?**


**Education**


+ Bachelors degree highly desired from an accredited college/university with a preference for Science, Engineering, Biochemistry, Biotechnology, Biology or Biomedical Engineering.


**Experience**


+ Minimum of 2 years experience in cGMP pharmaceuticals or biologics manufacturing and/or related quality position


**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.


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


Kelly Science & Clinical 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 (plus, did we mention we provide a ton of benefits ?). 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. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)
Posted: 2022-07-20 Expires: 2022-08-20

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Quality Compliance Specialist

Kelly Services
Carlsbad, CA 92008

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