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13 days old
Regulatory Affairs Technician
Kelly Services
Pennsauken, NJ 08110
Kelly Science and Clinical is searching for a full time direct hire Regulatory Affairs Technician in Pennsauken, NJ.
**Schedule:** Monday-Friday 7:30am - 5:30pm
**Pay:** $19.67-$25.33 per hour
**DUTIES & RESPONSIBILITIES:**
+ Maintain a solid and up to date understanding of all regulatory issues pertaining to the completion, review, and filing of production paperwork;
+ Maintain a solid and up to date understanding of all customer requirements and preferences pertaining to the completion, review, and filing of production paperwork;
+ Collect all production paperwork, ensuring that any missing paperwork is located;
+ Provide aggressive reporting and retraining for all incomplete, incorrect, or otherwise non-compliant paperwork;
+ Organize paperwork per established filing systems;
+ Review paperwork, ensuring that all process CCPs, quality specifications, and customer requirements have been met. Any product affected by deviations or missing records must be reported to QC and placed on QC hold;
+ Review COAs against specifications to ensure requirements have been met;
+ Manage filing system such that all completed and reviewed records are maintained and accessible for the amount of time required by customers and regulatory agencies;
+ Manage item number assignment, and document collection for all materials;
+ Release product;
+ Provide assistance/support as needed with customer, government, and third party audits;
+ Verify all holds in Locate-it;
+ Responding to and/or investigate any e-mails received throughout the day;
+ Receive incoming phone calls from customer/suppliers/Equipment companies, etc.;
+ Ability to work with multiple departments;
+ Good communication skills (both written and verbal);
+ Regular and predictable attendance is an essential function of this position;
+ Report food safety & quality problems to personnel with authority to initiate action.
**REQUIRED EDUCATION, SKILLS & EXPERIENCE:**
+ High School Diploma or GED;
+ Demonstrated ability to work independently, with limited supervision;
+ Extreme attention to detail;
+ Strong organizational ability;
+ Ability to work independently;
+ General computer proficiency (Word, Excel)
**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)
**Schedule:** Monday-Friday 7:30am - 5:30pm
**Pay:** $19.67-$25.33 per hour
**DUTIES & RESPONSIBILITIES:**
+ Maintain a solid and up to date understanding of all regulatory issues pertaining to the completion, review, and filing of production paperwork;
+ Maintain a solid and up to date understanding of all customer requirements and preferences pertaining to the completion, review, and filing of production paperwork;
+ Collect all production paperwork, ensuring that any missing paperwork is located;
+ Provide aggressive reporting and retraining for all incomplete, incorrect, or otherwise non-compliant paperwork;
+ Organize paperwork per established filing systems;
+ Review paperwork, ensuring that all process CCPs, quality specifications, and customer requirements have been met. Any product affected by deviations or missing records must be reported to QC and placed on QC hold;
+ Review COAs against specifications to ensure requirements have been met;
+ Manage filing system such that all completed and reviewed records are maintained and accessible for the amount of time required by customers and regulatory agencies;
+ Manage item number assignment, and document collection for all materials;
+ Release product;
+ Provide assistance/support as needed with customer, government, and third party audits;
+ Verify all holds in Locate-it;
+ Responding to and/or investigate any e-mails received throughout the day;
+ Receive incoming phone calls from customer/suppliers/Equipment companies, etc.;
+ Ability to work with multiple departments;
+ Good communication skills (both written and verbal);
+ Regular and predictable attendance is an essential function of this position;
+ Report food safety & quality problems to personnel with authority to initiate action.
**REQUIRED EDUCATION, SKILLS & EXPERIENCE:**
+ High School Diploma or GED;
+ Demonstrated ability to work independently, with limited supervision;
+ Extreme attention to detail;
+ Strong organizational ability;
+ Ability to work independently;
+ General computer proficiency (Word, Excel)
**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)
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Posted: 2022-05-11 Expires: 2022-06-11
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