The businesses of Merck KGaA, Darmstadt, Germany
Associate Quality Scientist
The businesses of Merck KGaA, Darmstadt, Germany, Miamisburg, Ohio, us, 45343
Overview
Work Location: Miamisburg, Ohio
Department: LS-SC-PEMQC Quality Control Analytics
Recruiter: Katherine Hall
Hiring Manager: Kathleen Benjamin
Your Role In this role you are responsible for microbiology related analysis including but not limited to in-process, drug substance, raw material and water sample endotoxin analysis. Responsibilities include but not are limited to:
Ensuring that suitable written records and work undertaken are kept in accordance with cGMP and company procedures.
Working within various internal departments to improve and execute processes used in an ICHQ7 environment.
Assisting with OOS/OOT investigations and root cause analysis investigations.
Interacting with the production and laboratory personnel regularly to ensure adequate communication and feedback for quality-related services to internal customers.
Maintaining and updating relevant Ops.
Who You Are Minimum Qualifications
Bachelor’s Degree in Biology, Chemistry, or other Life Science discipline.
1+ years of QC lab experience, specifically in Bioburden (USP 61), Growth Promotion Testing, and Endotoxin analysis.
Preferred Qualifications
Experience with aseptic technique and practices.
Experience with SOPs, cGMPs, GLP, GDP and quality control processes.
Experience with basic scientific/regulatory principles such as ICH Q7, 21CFR210/211, USP and EP.
Strong written and verbal communication skills.
Strong multi-tasking skills and teamwork mindset.
Strong computer skills, including proficiency in MS Word, MS Excel, MS PowerPoint.
Good problem-solving and time management skills.
Strong attention to detail and organizational skills.
Current API knowledge and/or experience.
Experience writing technical documents, reports, and troubleshooting.
Pay Range for this position: $23 - $42 / hour
The offer range represents the anticipated low and high end of the base pay compensation for this position. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors. Position may be eligible for sales or performance-based bonuses. Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other perquisites. For more information, information can be provided by inquiry.
RSREMD
Equal Employment Opportunity The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.
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Department: LS-SC-PEMQC Quality Control Analytics
Recruiter: Katherine Hall
Hiring Manager: Kathleen Benjamin
Your Role In this role you are responsible for microbiology related analysis including but not limited to in-process, drug substance, raw material and water sample endotoxin analysis. Responsibilities include but not are limited to:
Ensuring that suitable written records and work undertaken are kept in accordance with cGMP and company procedures.
Working within various internal departments to improve and execute processes used in an ICHQ7 environment.
Assisting with OOS/OOT investigations and root cause analysis investigations.
Interacting with the production and laboratory personnel regularly to ensure adequate communication and feedback for quality-related services to internal customers.
Maintaining and updating relevant Ops.
Who You Are Minimum Qualifications
Bachelor’s Degree in Biology, Chemistry, or other Life Science discipline.
1+ years of QC lab experience, specifically in Bioburden (USP 61), Growth Promotion Testing, and Endotoxin analysis.
Preferred Qualifications
Experience with aseptic technique and practices.
Experience with SOPs, cGMPs, GLP, GDP and quality control processes.
Experience with basic scientific/regulatory principles such as ICH Q7, 21CFR210/211, USP and EP.
Strong written and verbal communication skills.
Strong multi-tasking skills and teamwork mindset.
Strong computer skills, including proficiency in MS Word, MS Excel, MS PowerPoint.
Good problem-solving and time management skills.
Strong attention to detail and organizational skills.
Current API knowledge and/or experience.
Experience writing technical documents, reports, and troubleshooting.
Pay Range for this position: $23 - $42 / hour
The offer range represents the anticipated low and high end of the base pay compensation for this position. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors. Position may be eligible for sales or performance-based bonuses. Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other perquisites. For more information, information can be provided by inquiry.
RSREMD
Equal Employment Opportunity The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.
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