GMP Quality Specialist
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Job Location:
Methuen, MA - USA
Yearly Salary:
USD 90000 - 110000
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
About Tobin Scientific
Tobin Scientific is a leading provider of cold chain ambient storage and transport & logistics services for the biopharma industry. We proudly support a diverse clientele spanning life sciences academia government and more. Recognized for unwavering safety and reliability in the storage and transport of temperature-sensitive products we excel in serving the complex needs of the pharmaceutical and biotech sectors. Our capabilities extend to laboratory relocation principal investigator support and other logistic services. Tobin Scientifics all-encompassing approach and commitment to quality make us an industry innovator empowering our partners through the complexities of the biopharma industry.
Position Summary
The GMP Quality Specialist is responsible for providing day-to-day quality support for GMP warehousing and fleet operations. This role focuses on ensuring compliance with Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP) through quality data entry material checks and execution of quality system activities. The Quality Specialist will support operational excellence by maintaining high standards of documentation data integrity and compliance within the Quality Management System (QMS).
Location: Methuen (with up to 10% travel to New Jersey site)
Key Responsibilities
- Perform data entry and record management in support of GMP warehousing and labeling activities.
- Conduct quality checks of materials prior to shipment to ensure compliance with GMP and GDP requirements.
- Verify and review documentation for accuracy completeness and adherence to approved procedures.
- Support the implementation and maintenance of site quality systems including:
- Deviations - assist with documentation tracking and closure.
- CAPAs - support investigation summaries and effectiveness checks.
- Change Controls - assist in documentation and coordination of changes impacting materials or processes.
- Training - ensure training compliance and record accuracy for site personnel.
- Participate in routine warehouse walk-throughs to ensure compliance with GMP GDP and safety requirements.
- Maintain accurate timely and compliant records within electronic systems (e.g. QMS WMS etc.).
- Collaborate with cross-functional teams including Operations and Facilities to ensure quality standards are met.
- Assist with the review and approval of controlled documents such as SOPs logs and forms.
- Promote a culture of continuous improvement and compliance across the site.
- Travel up to 10% of the time to the companys New Jersey GMP warehouse to support quality system implementation.
Education
- Bachelors degree in Life Sciences (e.g. Biology Chemistry Biochemistry) Engineering or related technical discipline required.
Experience and Qualifications
- 2-3 years of experience in a GMP Quality role (e.g. Quality Assurance Quality Control or Quality Operations) within a pharmaceutical biotechnology or medical device environment.
- Strong understanding of GMP principles including documentation recordkeeping and data integrity.
- Experience supporting warehouse and fleet operations under GMP conditions preferred.
- Working knowledge of Quality Management Systems (QMS) and quality processes (deviations CAPA change control).
- Excellent attention to detail and accuracy in documentation and data entry.
- Proficiency with Microsoft Office Suite and familiarity with electronic systems such as eQMS or ERP platforms.
- Strong organizational and communication skills with the ability to work collaboratively across departments.
- Self-motivated reliable and able to prioritize tasks in a fast-paced compliance-driven environment.
Pay Range:
The annual salary range for this position is as follows:
$90000 - $110000.
Compensation depends on relevant experience and/or education specific skills function geographic location and other factors as applicable by law.
Tobin Scientific is an equal opportunity employer and values diversity at our company. We do not discriminate on the basis of race religion color national origin gender sexual orientation age marital status veteran status or disability status. We are committed to creating an inclusive environment for all our employees.
Required Experience:
IC
Key Skills
- Quality Assurance
- FDA Regulations
- Data Collection
- Food Safety Experience
- ISO 9001
- Mobile Devices
- Root cause Analysis
- Quality Systems
- OSHA
- Food Processing
- Quality Management
- cGMP
About Company
Tobin Scientific is the leading provider of biopharma cold chain, ambient storage, transportation and logistic services. cGMP compliant and ISO accredited.
