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19 days old

Manufacturing Specialist, GMP Investigations, El Segundo, CA/Culver City, CA

Kelly Services
El Segundo, CA 90245
**Manufacturing Specialist, GMP Investigations, El Segundo, CA/Culver City, CA**


**Position Type:** Direct Hire


**POSITION SUMMARY**


We are seeking an experienced Manufacturing Investigator for Cell Therapy products. The candidate would be responsible for writing and owning quality records for GMP Manufacturing Operation activities in support of the release of the product. This position provides a unique opportunity to make an immediate impact and lay the foundation for processes and procedures in a fast-paced dynamic environment. This position will be located at one of our clinical manufacturing facilities in El Segundo or Culver City, CA, and reports to the Manufacturing Manager GMP Supporti


**ESSENTIAL FUNCTIONS**


+ Support clinical product final disposition by leading investigations for significant deviations, change controls, and corrective/preventative actions and manage closure within the established timelines.

+ Demonstrate continuous improvement with respect to increasing job knowledge and proficiency related to cell therapy, as well as technical understanding/problem-solving capability.

+ Responsible for organizing data and preparing appropriate documentation, including presentation materials, for assigned projects.

+ Perform document change control activities. Write, edit, and review of controlled documents to ensure documents comply with applicable regulatory requirements.

+ Participate in regular site and Quality/Manufacturing meetings.

+ Participate in audits and regulatory inspections as assigned.

+ Other duties as assigned


**EDUCATION/REQUIREMENTS**


+ Bachelors degree in a biological science, chemistry, or related science field.

+ Minimum of 2-4 years of experience in the pharmaceutical/biopharmaceutical industry.

+ Good knowledge of biologics cGMP manufacturing ideally including recombinant protein and cell therapy cGMP manufacturing.


**CORE COMPETENCIES - KNOWLEDGE, SKILLS, & ABILITIES:**


+ Strong verbal, written, and interpersonal communication skills.

+ Proficiency in computer use and Microsoft Office applications.

+ Proven ability to work independently and analyze and resolve issues that impact quality.

+ Attention to detail with strong analytical and problem-solving skills.

+ Ability to operate in a fast-paced, multi-disciplinary industrial environment while managing multiple priorities.

+ Exceptional organization and time-management skills. Ability to deliver under deadlines.


**For Immediate Consideration, Apply Today! Questions? Call Grace at 714.253.7656, Email at grap467@kellyservices.com, or schedule a time to connect directly follow the link:** **https://calendly.com/gracepiper/15min-1**


**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: 2021-04-19 Expires: 2021-05-20

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Manufacturing Specialist, GMP Investigations, El Segundo, CA/Culver City, CA

Kelly Services
El Segundo, CA 90245

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