Senior Associate Product Specification
Senior Associate Product Specification
Posted on :
24-01-2025
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Job Description
Job Title: Senior Associate Product Specification
Job Location: Home KS 66438 USA
Job Location Type: Remote
Job Contract Type: Fulltime
Job Seniority Level: MidSenior level
About Technical Operations
BioMarin’s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers technicians scientists and support staff build and maintain BioMarin’s cuttingedge manufacturing processes and sites provide quality assurance and quality control to ensure we meet regulatory standards and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients.
Senior Associate Product Specification Role Overview The Product Specification Senior Associate is a critical role within BioMarin’s Product Quality Lifecycle Management organization responsible for the management and maintenance of product specifications throughout the product lifecycle. This individual will ensure that all specifications including those for reference standards intermediates drug substances and drug products are accurate compliant and aligned with regulatory requirements. This position will collaborate crossfunctionally to ensure accurate and consistent product documentation enabling efficient product release regulatory compliance and product lifecycle management. The role requires a strong focus on quality attention to detail and proactive problemsolving to address specificationsrelated challenges and maintain compliance with evolving regulatory requirements. This position will play a vital role in ensuring the quality and compliance of BioMarin’s innovative lifesaving products supporting their successful development commercialization and lifecycle management. Key Responsibilities
Equal Opportunity Employer/Veterans/Disabled
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity national origin or protected veteran status and will not be discriminated against on the basis of disability.
Who We Are
BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health.
Since our founding in 1997 we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines using a number of treatment modalities.
Using our unparalleled expertise in genetics and molecular biology we develop medicines for patients with significant unmet medical need. We enlist the best of the best – people with the right technical expertise and a relentless drive to solve real problems – and create an environment that empowers our teams to pursue bold innovative science. With this distinctive approach to drug discovery we’ve produced a diverse pipeline of commercial clinical and preclinical candidates that have wellunderstood biology and provide an opportunity to be firsttomarket or offer a substantial benefit over existing therapeutic options.
BioMarin’s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers technicians scientists and support staff build and maintain BioMarin’s cuttingedge manufacturing processes and sites provide quality assurance and quality control to ensure we meet regulatory standards and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients.
Senior Associate Product Specification Role Overview The Product Specification Senior Associate is a critical role within BioMarin’s Product Quality Lifecycle Management organization responsible for the management and maintenance of product specifications throughout the product lifecycle. This individual will ensure that all specifications including those for reference standards intermediates drug substances and drug products are accurate compliant and aligned with regulatory requirements. This position will collaborate crossfunctionally to ensure accurate and consistent product documentation enabling efficient product release regulatory compliance and product lifecycle management. The role requires a strong focus on quality attention to detail and proactive problemsolving to address specificationsrelated challenges and maintain compliance with evolving regulatory requirements. This position will play a vital role in ensuring the quality and compliance of BioMarin’s innovative lifesaving products supporting their successful development commercialization and lifecycle management. Key Responsibilities
- Responsible for the product specification document lifecycle: establishes maintains and retires product specifications for reference standards intermediates drug substances and drug products.
- Owner and/or approver of change control records for product specification documents in the QMS.
- Works closely and effectively with other team members demonstrating strong teamwork communication and interpersonal skills to achieve departmental goals.
- Collaborates and builds effective relationships across multiple levels in Quality Technical Development Services Supply Chain and Regulatory Affairs.
- Serves as impact assessor for change controls evaluating proposed changes and identifying their impact on product specifications documents and related processes.
- Assists with managing specificationrelated deviations by helping to investigate root causes working closely with crossfunctional teams to support the implementation of corrective and preventive actions and contributing to timely resolution in compliance with quality and regulatory standards.
- Tracks and reports key performance metrics related to specification management (e.g. timeliness of updates) ensuring alignment with organizational goals and identifying opportunities for continuous improvement.
- Participates in process improvement initiatives to enhance the efficiency accuracy and compliance of specification management systems and workflows. Partners with crossfunctional teams to identify opportunities for streamlining specificationrelated processes and implement solutions.
- Responsible to support the maintenance and updates functionspecific guidelines and SOPs.
- Supports regulatory inspections and internal audits providing necessary documentation and expertise.
- Authors other technical documents such as manual CofAs as needed.
- BA/BS in life sciences or related field required.
- 3 years of experience in product specification management technical writing or related roles in the Biotechnology Pharmaceutical Medical Device or other highly regulated industry.
- Strong understanding of cGMPs principles concepts practices and standards.
- Excellent organizational skills with attention to detail.
- Proven ability to manage multiple projects and meet deadlines in a fastpaced environment.
- Excellent written and verbal skills; collaborative mindset with the ability to communicate and work effectively across functions.
Equal Opportunity Employer/Veterans/Disabled
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity national origin or protected veteran status and will not be discriminated against on the basis of disability.
Who We Are
BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health.
Since our founding in 1997 we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines using a number of treatment modalities.
Using our unparalleled expertise in genetics and molecular biology we develop medicines for patients with significant unmet medical need. We enlist the best of the best – people with the right technical expertise and a relentless drive to solve real problems – and create an environment that empowers our teams to pursue bold innovative science. With this distinctive approach to drug discovery we’ve produced a diverse pipeline of commercial clinical and preclinical candidates that have wellunderstood biology and provide an opportunity to be firsttomarket or offer a substantial benefit over existing therapeutic options.
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Employment Type
Full Time
Key Skills
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