Senior Specialist, SMDQ Rahway API Disposition (Product Quality Release) Job - United States
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.
The Senior Specialist, SMDQ Rahway API Disposition reports to the Director, SMDQ Rahway API and supports development quality activities at the Rahway site.
Primary responsibilities are:
- The successful candidate will have accountability for drug substance batch release and related duties under GMP, ensuring compliant clinical drug substance supply.
- Participate and/or lead quality related projects, and process or quality system improvements.
- Drives results and solves complex problems.
Responsibilities include, but are not limited to:
- Develop and implement efficient business solutions and effective quality processes.
- Lead, participate, collaborate in cross functional projects. Apply critical decision making and project management skills to drive results.
- Develop and apply expertise, provide guidance and interpretation of Good Manufacturing Practice (GMP) and related regulatory requirements, standards, and guidance documents.
- Audit batch records and related document types such as method validation, transfer, stability data or reports. Make batch release or reject decisions.
- Investigate and resolve deviations and related non-conformances vs. GMP requirements and procedures.
- Participate in quality alerts or quality manual changes as needed to meet cGMP requirements.
- Author, review, and/or approve procedures (SOP) within Quality and for or with functional areas.
- Proactively identify, develop, and implement areas for work process improvement and efficiency.
- Perform all other quality review or oversight tasks and projects as assigned or delegated.
- Conduct all work meeting high standards for quantity, integrity, quality, and GMP compliance.
- Bachelor degree in a Science or Engineering discipline (chemistry, biology, biochemistry, microbiology, engineering)
- Minimum of five years of experience in pharmaceutical, biotechnology, chemical, medical device, or a closely related industry.
- Experience in one or more functional areas such as quality control, quality assurance, laboratory, manufacturing, production, regulatory, research, development, supply chain, design, engineering.
- Good Manufacturing Practice (GMP) or related drug regulation knowledge and experience.
- Exhibit Merck leadership behaviors and communication and collaboration skills to work effectively with stakeholders and functions.
- Ability to work in a visible position to deliver results and make sound decisions.
- Ability to work across functions and sites as necessary.
- Ability to work in dynamic R&D environment with rapidly changing needs.
- Working knowledge with drug R&D or clinical supply functions or work processes.
- Subject matter knowledge with drug substances or API.
- Track record for creating measurable results.
- Effective skills in leadership, collaboration, teamwork, conflict management.
- Advanced degree will be given preference.
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 firstname.lastname@example.org.
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Visa sponsorship is not available for this position.
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Merck is an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.
Job: Clinical, Non Clinical Quality Assurance
Job Title:Sr. Spclst, Quality Assurance
Primary Location: NA-US-NJ-Rahway
Employee Status: Regular
Travel: Yes, 10 % of the Time
Number of Openings: 1
Company Trade Name:Merck
Nearest Major Market: New York City
Nearest Secondary Market: Newark
Job Segment: Biochemistry, Microbiology, Chemical Research, Biotech, Medical, Science, Engineering, Healthcare