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10 days old

Senior Quality Control Analyst Compliance Specialist

Kelly Services
Plantation, FL 33388
**Job Title:** Senior Quality Control Analyst Compliance Specialist


**Location:** Plantation, FL


**Salary:** $80,000 + great benefits


**Responsibilities:**


+ To ensure compliance with regulatory and corporate requirements, responsible for reviewing Quality Control documents and records, including, but not limited to, qualification, validation and stability protocols and reports, analytical/test reports, standard operating procedures SOP , instrument/equipment records, certificates of analysis/testing and periodic summary reports.

+ Responsible for quality control analytical data review to ensure compliance with Good Documentation Practices GDP and data verification requirements per 21CFR210/211.

+ Responsible for administering the training program within the Quality Control department.

+ Responsible for origination or review of exception documents and records related to Quality Control operations including, but not limited to Out of Specification OOS , Out of Trend OOT , Deviation, CAPA, and Change Control Reports, to ensure compliance with regulatory and corporate requirements. Reports to: Quality Control Analytical, Senior Manager or higher Specific Duties.

+ Ensure quality control analytical data comply with Good Manufacturing Practices GMP and Good Documentation Practices GDP .

+ Ensure quality control documents and records comply with GMP, GDP and corporate requirements.

+ Ensure that exception documents and records comply with GMP, GDP and corporate requirements, and are closed prior to analytical testing disposition.

+ Ensure QC documents are developed in accordance with domestic and international regulatory requirements and corporate standards.

+ Author/prepare test procedures, SOPs, protocols, reports and other documents as assigned.

+ Ensure analytical data collection per 21CFR Part 11 compliance, execute data analysis, and verify data integrity.

+ Oversee the administration of the QC training program and assist in the execution of regulatory compliant QC employee training, including but not limited to Good Documentation practices, Laboratory Control process and Data Integrity as required,

+ Develop and implement codified procedures for result/report receiving, review and recording

+ Assist in Client/Regulatory audit responses are addressed on-time.

+ Establish and implement self-inspection program for the Quality Control laboratory.

+ Ensure QC equipment and instruments are maintained in accordance with established qualification and calibration criteria and schedules.

+ Monitor laboratory notebooks to ensure issuance, review, and archival are conducted in a timely manner in accordance with established standards.

+ Conduct analytical testing and other duties, as assigned.


**Requirements:**


**Education** :


+ Bachelors in biological or biochemical sciences or related field.


**Experience** :


+ Must have at least three years of direct work experience in FDA regulated environment.

+ The candidate will be a problem-solver with the ability to exercise sound judgment under challenging circumstances.

+ Excellent written and verbal communication skills with the ability to effectively promote intra-and interdepartmental cooperation.

+ Knowledge of GMP, ICH and compendial requirements and their application.


**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: 2022-01-10 Expires: 2022-02-10

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Senior Quality Control Analyst Compliance Specialist

Kelly Services
Plantation, FL 33388

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