Senior Quality Control Specialist
Randstad USA
Social Circle, GA (In Person)
$156,301 Salary, Full-Time
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Job Description
location:
Social Circle, Georgia job type: Contract salary: $70.00 - 80.29 per hour work hours: 9 to 5 education: Bachelors responsibilities: Perform compendial assessments to ensure compliance with current regulatoryrequirements and pharmacopeial standards.Author and review technical documents, including protocols, standard operating procedures (SOPs), and analytical methodologies.
Design and coordinate analytical method onboarding activities, including execution planning, training, and documentation.
Lead and manage the qualification of critical materials, ensuring fitness for use in analytical testing.
Oversee change control management processes, including risk assessment, documentation, and implementation.
Manage Corrective and Preventive Actions (CAPAs) related to analytical processes and support timely closure of quality events.
Act as a Subject Matter Expert (SME) by providing technical guidance and troubleshooting support to laboratory testing teams.
Collaborate effectively across departments to ensure alignment and successful execution of cross-functional initiatives.
Identify and drive continuous improvements in analytical methods and laboratory workflows to enhance efficiency and compliance.
Conduct data trending and analysis of laboratory processes and analytical performance on a routine basis to identify trends and areas for improvement.
Collaborate as a QC representative with global teams on both global and local projects and take the initiative for improvements.
qualifications:
Qualifications Requires bachelor's degree in science, engineering or other related technical field. 4+ years of related experience in pharmaceutical or similar regulated industry.Strong QC Microbiology experience preferred (testing, sampling, processes)Must know quality laboratory operations and government regulations pertaining to pharmaceutical and medical device manufacturing labs.
Must have the ability to manage multiple tasks and responsibilities for the QC Lab.
Must have the ability of managing complex projects and resolving complex lab issues.
Must possess excellent technical and interpersonal skills, and be able to communicate with all level personnel and regulatory authorities.
Should have advanced knowledge in Statistical Analysis and cGMP standards. Strong leadership, project and people management skills, and ability to make critical decisions.
Strong understanding of business and/or industry. #LI-AM1 skills: Microbiology, SOP Development, Good Manufacturing Practices (GMP), Corrective and Preventive Actions (CAPA), Quality Control (QC)
Equal Opportunity Employer:
Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com. Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility). This posting is open for thirty (30) days. job detailssummary$70 - $80.29 per hourcontractbachelor degreecategorylife, physical, and social science occupationsreference53061job details job summary: The role of the Senior Quality Control Specialist is to provide technical expertise and support for the Operational Support functions of the QC Laboratory.
location:
Social Circle, Georgia job type: Contract salary: $70.00 - 80.29 per hour work hours: 9 to 5 education: Bachelors responsibilities: Perform compendial assessments to ensure compliance with current regulatoryrequirements and pharmacopeial standards.Author and review technical documents, including protocols, standard operating procedures (SOPs), and analytical methodologies.
Design and coordinate analytical method onboarding activities, including execution planning, training, and documentation.
Lead and manage the qualification of critical materials, ensuring fitness for use in analytical testing.
Oversee change control management processes, including risk assessment, documentation, and implementation.
Manage Corrective and Preventive Actions (CAPAs) related to analytical processes and support timely closure of quality events.
Act as a Subject Matter Expert (SME) by providing technical guidance and troubleshooting support to laboratory testing teams.
Collaborate effectively across departments to ensure alignment and successful execution of cross-functional initiatives.
Identify and drive continuous improvements in analytical methods and laboratory workflows to enhance efficiency and compliance.
Conduct data trending and analysis of laboratory processes and analytical performance on a routine basis to identify trends and areas for improvement.
Collaborate as a QC representative with global teams on both global and local projects and take the initiative for improvements.
qualifications:
Qualifications Requires bachelor's degree in science, engineering or other related technical field. 4+ years of related experience in pharmaceutical or similar regulated industry.Strong QC Microbiology experience preferred (testing, sampling, processes)Must know quality laboratory operations and government regulations pertaining to pharmaceutical and medical device manufacturing labs.
Must have the ability to manage multiple tasks and responsibilities for the QC Lab.
Must have the ability of managing complex projects and resolving complex lab issues.
Must possess excellent technical and interpersonal skills, and be able to communicate with all level personnel and regulatory authorities.
Should have advanced knowledge in Statistical Analysis and cGMP standards. Strong leadership, project and people management skills, and ability to make critical decisions.
Strong understanding of business and/or industry. #LI-AM1 skills: Microbiology, SOP Development, Good Manufacturing Practices (GMP), Corrective and Preventive Actions (CAPA), Quality Control (QC)
Equal Opportunity Employer:
Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com. Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility). This posting is open for thirty (30) days.
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