The businesses of Merck KGaA, Darmstadt, Germany
Manager, Quality Control
The businesses of Merck KGaA, Darmstadt, Germany, Saint Louis, Missouri, United States, 63146
Work Location: St. Louis, Missouri
Shift:
Department: LS-SC-UYKQD Cherokee QC Microbiology
Recruiter: Leah S Westley
Your Role: As Quality Control Manager (Microbiology) you will be accountable for management of a GMP Quality Control Microbiology and Environmental Monitoring department supporting microbiological testing of APIs according ICH Q7 and 21CFR regulations; oversee the Quality Control activities associated with microbiological method validation and transfer; testing of product; Environmental monitoring; training on aseptic technique and test methods; OOS/OOT investigations; deviation and CAPA management.
Management and development of Quality Control microbiology department, consisting of 2 groups totaling 20+ employees.
Accountable to meet business and quality performance metrics through continuous process improvement initiatives.
Provide scientific guidance on complex manufacturing investigations and resolution of out-of-specification (OOS) and out-of-trend (OOT) testing results and ensure data integrity.
Detect quality problems within the department, prepare investigation reports, and implement corrective actions in a timely manner. Manage test deviation as necessary with QA and notify it to management.
Collaborate cross functionally as needed to ensure the Quality Management System processes are implemented in accordance with established procedures.
Attend project team meetings as the QC microbiology representative and works closely with the team to ensure on-time delivery.
Interface with internal and external customers on a regular basis to communicate project status, resolve issues; implement methods, techniques and evaluation criteria for products and processes.
Develop and manage the department budget and capital expenditure budget. Interact with internal and external customers on regular basis.
Participates and supports regulatory/customer audits.
Other duties as required.
Who You Are: Minimum Qualifications:
Bachelor's degree in a scientific discipline or related discipline and/or certification in Quality Management or related area required. Master’s degree in a scientific discipline or related discipline desired but not required.
10+ years of successful demonstration of the key responsibilities as presented above with in biologics or pharmaceuticals and previous people leadership experience.
Demonstrated experience working in a highly matrixed, GMP manufacturing setting.
Strong understanding of microbiology (Endotoxin and Bioburden testing); contamination control; Cleanrooms and Aseptic manufacturing; Environmental monitoring etc.
Strong understanding of microbiological methodology and laboratory techniques, specifically USP ; USP
and USP .
Knowledge of Laboratory Information Management System (LIMS).
Preferred Qualifications:
Demonstrated leadership, people development and team building skills.
Requires prior managerial experience.
Solid track records in method development, method verification and validation
Strong written and verbal communication skills.
Strong problem solving skills.
Strong computer skills, including word processing, and Quality systems databases.
Knowledge of GMP, Good Documentation Practices (GDP), or Good Laboratory Practices (GLP).
Knowledge of FDA practices and guidelines.
Knowledge of pharma/biotech bulk and finished product manufacturing and microbiological testing requirements.
Expertise in aseptic principles and practices
Knowledge of ICH Q7A, 21CFR, Eudralex GMP regulations, USP and EP pharmacopeia requirements
Pay Range for this position: $134,400-$201,600
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 click here.
Equal Employment Opportunity Statement 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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Your Role: As Quality Control Manager (Microbiology) you will be accountable for management of a GMP Quality Control Microbiology and Environmental Monitoring department supporting microbiological testing of APIs according ICH Q7 and 21CFR regulations; oversee the Quality Control activities associated with microbiological method validation and transfer; testing of product; Environmental monitoring; training on aseptic technique and test methods; OOS/OOT investigations; deviation and CAPA management.
Management and development of Quality Control microbiology department, consisting of 2 groups totaling 20+ employees.
Accountable to meet business and quality performance metrics through continuous process improvement initiatives.
Provide scientific guidance on complex manufacturing investigations and resolution of out-of-specification (OOS) and out-of-trend (OOT) testing results and ensure data integrity.
Detect quality problems within the department, prepare investigation reports, and implement corrective actions in a timely manner. Manage test deviation as necessary with QA and notify it to management.
Collaborate cross functionally as needed to ensure the Quality Management System processes are implemented in accordance with established procedures.
Attend project team meetings as the QC microbiology representative and works closely with the team to ensure on-time delivery.
Interface with internal and external customers on a regular basis to communicate project status, resolve issues; implement methods, techniques and evaluation criteria for products and processes.
Develop and manage the department budget and capital expenditure budget. Interact with internal and external customers on regular basis.
Participates and supports regulatory/customer audits.
Other duties as required.
Who You Are: Minimum Qualifications:
Bachelor's degree in a scientific discipline or related discipline and/or certification in Quality Management or related area required. Master’s degree in a scientific discipline or related discipline desired but not required.
10+ years of successful demonstration of the key responsibilities as presented above with in biologics or pharmaceuticals and previous people leadership experience.
Demonstrated experience working in a highly matrixed, GMP manufacturing setting.
Strong understanding of microbiology (Endotoxin and Bioburden testing); contamination control; Cleanrooms and Aseptic manufacturing; Environmental monitoring etc.
Strong understanding of microbiological methodology and laboratory techniques, specifically USP ; USP
and USP .
Knowledge of Laboratory Information Management System (LIMS).
Preferred Qualifications:
Demonstrated leadership, people development and team building skills.
Requires prior managerial experience.
Solid track records in method development, method verification and validation
Strong written and verbal communication skills.
Strong problem solving skills.
Strong computer skills, including word processing, and Quality systems databases.
Knowledge of GMP, Good Documentation Practices (GDP), or Good Laboratory Practices (GLP).
Knowledge of FDA practices and guidelines.
Knowledge of pharma/biotech bulk and finished product manufacturing and microbiological testing requirements.
Expertise in aseptic principles and practices
Knowledge of ICH Q7A, 21CFR, Eudralex GMP regulations, USP and EP pharmacopeia requirements
Pay Range for this position: $134,400-$201,600
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 click here.
Equal Employment Opportunity Statement 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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