Senior Specialist Quality Control Job
- Employer
- Merck
- Location
- West Point PA
- Closing date
- Jan 30, 2017
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Job Details
Senior Specialist Quality Control-QUA005345
Description
Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. Today, we are building a new kind of healthcare company – one that is ready to help create a healthier future for all of us.
Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.
Job Overview - Basic Functions & Responsibility
Essential function(s) includes, but is not limited to:
The incumbent is responsible for supporting and troubleshooting assay methods used to test finished products and processes. Partners with Laboratory Technical Support (LTS) senior staff to develop and improve release testing methods to ensure the quality of vaccines and sterile pharmaceutical products. Under the direction of senior staff, provides analytical support to Vaccine Laboratory Operations, Vaccine Operations and MRL in method development and manufacturing investigations. Utilizes knowledge of their field of scientific expertise and techniques gained through academic training and experience in analytical methodology.
Primary activities include, but are not limited to:
Project Responsibilities
1. Independently works on projects with guidance from LTS senior staff related to the development of new and improvement of existing assay methods for licensed and developmental products.
2. Qualifies critical reagents and controls for use in release and stability testing. Incumbent independently performs and completes reagent Qualifications by authoring protocols with guidance from senior staff, performing/organizing experiments and authoring reports.
3. Conducts experiments and documents results for the purpose of validating enhancements to methods used in release and stability testing. Partners with appropriate regulatory, MRL and LTS senior staff to perform analytical assessment and transfer of new methods to Laboratory Operations.
4. Under the guidance of LTS senior staff, develop, validate and transfer improved analytical methods to Laboratory Operations.
5. With guidance from LTS senior staff, performs analytical investigations in relation to quality issues that may be involved in product recalls, market withdrawals, process abnormalities and manufacturing or packaging process changes.
6. Proactively supports Laboratory Operations during investigations of invalid/atypical results or shifts/trends in the performance of analytical testing.
7. Plans and carries out assignments. Incumbent strives to work independently in the design of experiments and seeks guidance on protocol design and data interpretation. Strives to provide creative solutions to problems that may arise during an investigation.
8. Demonstrates the ability to work proficiently with the Quality business systems.
9. Authors comprehensive technical documents requiring minimal review and revision.
10. Demonstrates leadership to independently implement, execute and manage projects.
Technical Competence
1. Responsible for conducting routine experimental analysis and may be required to perform and schedule routine release testing, as defined by functional responsibility, with minimal supervision.
2. Independently executes training and implementation of new and existing technology for routine analytical testing.
3. Responsible for using safe laboratory techniques and maintaining work area in a clean, orderly manner adhering to WP Safety Policies and cGMPs.
Quality Responsibilities
1. Conducts all analytical and project responsibilities according to the highest quality standards.
2. Partners on analytical problem solving while insuring compliance with cGMP and regulatory requirements to support the evaluation of Merck products for safety, efficacy and potency.
3. Responsibilities include proper documentation of test results, related data and necessary calculations in a manner consistent with cGMPs.
Qualifications
Education Minimum Requirement:
- B.S., M.S., Ph.D. in appropriate Biological science, Biochemistry, Chemistry or Engineering field.
- B.S. with a minimum of 3-4 years laboratory experience; M.S., Ph.D. with minimum of 2-3 years laboratory experience.
- Demonstrated leadership and teamwork skills, and ability to work independently.
- Demonstrated effective written, communication, analytical and problem solving skills.
Required Experience and Skills:
- Good verbal and written communication skills with the ability to work in a team setting.
- Good interpersonal skills.
- Demonstrated ability or aptitude for continuous learning and analytical problem solving.
- A background including analytical troubleshooting, potency method improvement and validation, statistics and cGMP regulations is preferred.
- Specific Methods: Biochemistry Methodology, ELISA, Western Blot, Protein assays, Gel assays, Densitometry, Endotoxin (LAL).
Preferred Experience and Skills:
- A background including experience with analytical testing and analytical troubleshooting for the following analytical test methods: Statistical Software expertise (JMP, Minitab, etc.), Liquid Handling equipment, Capillary Electrophoresis, Cell Culture, ELISA Based assays.
Our employees are the key to our company’s success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Our Company’s benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives. If you need an accommodation for the application process please email us at staffingaadar@merck.com.
Search Firm Representatives Please Read Carefully:
Merck & Co., Inc. is not accepting unsolicited assistance from search firms for this employment opportunity. Please, no phone calls or emails. All resumes submitted by search firms to any employee at Merck via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck. No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means.
Visa sponsorship is not available for this position.
For more information about personal rights under Equal Employment Opportunity, visit:
EEOC Poster
EEOC GINA Supplement
Merck is an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.
Job: Quality Lab Related
Job Title:Sr. Spclst, Quality Control
Primary Location: NA-US-PA-West Point
Employee Status: Regular
Travel: Yes, 10 % of the Time
Number of Openings: 1
Shift (if applicable): 1st
Hazardous Materials: Biosafety Level -2
Company Trade Name:Merck
Description
Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. Today, we are building a new kind of healthcare company – one that is ready to help create a healthier future for all of us.
Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.
Job Overview - Basic Functions & Responsibility
Essential function(s) includes, but is not limited to:
The incumbent is responsible for supporting and troubleshooting assay methods used to test finished products and processes. Partners with Laboratory Technical Support (LTS) senior staff to develop and improve release testing methods to ensure the quality of vaccines and sterile pharmaceutical products. Under the direction of senior staff, provides analytical support to Vaccine Laboratory Operations, Vaccine Operations and MRL in method development and manufacturing investigations. Utilizes knowledge of their field of scientific expertise and techniques gained through academic training and experience in analytical methodology.
Primary activities include, but are not limited to:
Project Responsibilities
1. Independently works on projects with guidance from LTS senior staff related to the development of new and improvement of existing assay methods for licensed and developmental products.
2. Qualifies critical reagents and controls for use in release and stability testing. Incumbent independently performs and completes reagent Qualifications by authoring protocols with guidance from senior staff, performing/organizing experiments and authoring reports.
3. Conducts experiments and documents results for the purpose of validating enhancements to methods used in release and stability testing. Partners with appropriate regulatory, MRL and LTS senior staff to perform analytical assessment and transfer of new methods to Laboratory Operations.
4. Under the guidance of LTS senior staff, develop, validate and transfer improved analytical methods to Laboratory Operations.
5. With guidance from LTS senior staff, performs analytical investigations in relation to quality issues that may be involved in product recalls, market withdrawals, process abnormalities and manufacturing or packaging process changes.
6. Proactively supports Laboratory Operations during investigations of invalid/atypical results or shifts/trends in the performance of analytical testing.
7. Plans and carries out assignments. Incumbent strives to work independently in the design of experiments and seeks guidance on protocol design and data interpretation. Strives to provide creative solutions to problems that may arise during an investigation.
8. Demonstrates the ability to work proficiently with the Quality business systems.
9. Authors comprehensive technical documents requiring minimal review and revision.
10. Demonstrates leadership to independently implement, execute and manage projects.
Technical Competence
1. Responsible for conducting routine experimental analysis and may be required to perform and schedule routine release testing, as defined by functional responsibility, with minimal supervision.
2. Independently executes training and implementation of new and existing technology for routine analytical testing.
3. Responsible for using safe laboratory techniques and maintaining work area in a clean, orderly manner adhering to WP Safety Policies and cGMPs.
Quality Responsibilities
1. Conducts all analytical and project responsibilities according to the highest quality standards.
2. Partners on analytical problem solving while insuring compliance with cGMP and regulatory requirements to support the evaluation of Merck products for safety, efficacy and potency.
3. Responsibilities include proper documentation of test results, related data and necessary calculations in a manner consistent with cGMPs.
Qualifications
Education Minimum Requirement:
- B.S., M.S., Ph.D. in appropriate Biological science, Biochemistry, Chemistry or Engineering field.
- B.S. with a minimum of 3-4 years laboratory experience; M.S., Ph.D. with minimum of 2-3 years laboratory experience.
- Demonstrated leadership and teamwork skills, and ability to work independently.
- Demonstrated effective written, communication, analytical and problem solving skills.
Required Experience and Skills:
- Good verbal and written communication skills with the ability to work in a team setting.
- Good interpersonal skills.
- Demonstrated ability or aptitude for continuous learning and analytical problem solving.
- A background including analytical troubleshooting, potency method improvement and validation, statistics and cGMP regulations is preferred.
- Specific Methods: Biochemistry Methodology, ELISA, Western Blot, Protein assays, Gel assays, Densitometry, Endotoxin (LAL).
Preferred Experience and Skills:
- A background including experience with analytical testing and analytical troubleshooting for the following analytical test methods: Statistical Software expertise (JMP, Minitab, etc.), Liquid Handling equipment, Capillary Electrophoresis, Cell Culture, ELISA Based assays.
Our employees are the key to our company’s success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Our Company’s benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives. If you need an accommodation for the application process please email us at staffingaadar@merck.com.
Search Firm Representatives Please Read Carefully:
Merck & Co., Inc. is not accepting unsolicited assistance from search firms for this employment opportunity. Please, no phone calls or emails. All resumes submitted by search firms to any employee at Merck via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck. No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means.
Visa sponsorship is not available for this position.
For more information about personal rights under Equal Employment Opportunity, visit:
EEOC Poster
EEOC GINA Supplement
Merck is an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.
Job: Quality Lab Related
Job Title:Sr. Spclst, Quality Control
Primary Location: NA-US-PA-West Point
Employee Status: Regular
Travel: Yes, 10 % of the Time
Number of Openings: 1
Shift (if applicable): 1st
Hazardous Materials: Biosafety Level -2
Company Trade Name:Merck
Company
Our vision is to make a difference in the lives of people globally through our innovative medicines, vaccines, biologic therapies, consumer health and animal products. We aspire to be the best healthcare company in the world and are dedicated to providing leading innovations and solutions for tomorrow.
We have made it our mission to provide innovative, distinctive products and services that save and improve lives, satisfy customer needs and to be recognized as a great place to work
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