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14 days old

Quality and Compliance Specialist

Kelly Services
Riverview, MI 48193
  • Jobs Rated
    23rd
Kelly Scientific is seeking a **Quality and Compliance Specialist** in **Riverview, MI.**


**Direct Hire**


**Shift:** 4pm-2:30am (training on 1st shift) week1 Mon, Tue, Fri, Sat week 2 Sun, Tue, Wed, Thu


**Compensation:** Based on experience


_Relocation available!_


**Job Responsibilities:**


+ Review any analytical data generated in the analytical lab (QC/AS) including but not limited to IPC, raw materials, intermediates, finished products, cleaning verification/validation, stability, and method validation data according to cGMP, GDP, in a timely manner.

+ Ensure compliance with internal approved procedures, specifications and protocols of all generated data

+ Review all planned and unplanned deviations for accuracy, completeness and compliance to data integrity, written procedures and CGMP regulations

+ Review of out-of-specification or out-of-trend investigations and/or deviations for accuracy, completeness and compliance to data integrity, written procedures, and cGMP regulations

+ Perform and or support lab investigations (e.g. OOS, deviations, CAPAs)

+ Review of reports for accuracy and completeness. Reports may include but not limited to: method validation reports, stability reports, lab equipment and instrumentation Calibration and Preventive Maintenance (PM) Reports, etc.

+ Assist in the preparation of new or revised documentation as required, including but not limited to test methods, SOPs, protocols, reports and/or specifications.

+ Participate in the implementation of continuous improvement initiatives as they relate to quality activities (e.g., introduction of new technology and automation with respect to data acquisition, electronic review, quality management systems, LIMS, etc.)

+ Revise via change control documentation as required

+ Perform other related assignments and projects as required

+ Provide data and information pertaining to lab or systems for internal or external clients as requested


**Qualifications:**


+ Bachelors degree in Chemistry, Biochemistry or related field.

+ Minimum two (2) to five (5) years of experience in using HPLC, GC, and/or related analytical techniques.

+ QC data review experience required.

+ Good knowledge of CGMP requirements, ICH, FDA guidelines.

+ Knowledge of analytical instrumentation and techniques.

+ Skills in interpreting and trending analytical data and instrumentation/equipment software.

+ Knowledge of Agilent OpenLab, SAP, Trackwise, LIMS a plus.

+ Understanding of method development, validation, transfer and stability requirements.

+ Strong communication skills, both written and verbal.


**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)

Jobs Rated Reports for Compliance Officer

Posted: 2022-06-13 Expires: 2022-07-25

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Quality and Compliance Specialist

Kelly Services
Riverview, MI 48193

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Compliance Officer
23rd2019 - Compliance Officer
Overall Rating: 23/199
Median Salary: $67,870

Work Environment
Very Good
22/220
Stress
Very Low
2/220
Growth
Poor
176/220
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