GMP Operational Quality Specialist (Onsite)

Job Description

The Quality Specialist will provide QA support for manufacturing operations analytical laboratory operations and materials management for the internal programs at Vertex Manufacturing Center (VMC) Boston MA.

The position will be a part of the QA operation floor support team. This role will review & support activities related to product disposition including batch data batch records deviations in-process data EM data QC release testing and other quality systems documentation. The Quality Specialist supports or executes daily activities related to equipment or instrumentation supporting Facilities Utilities Manufacturing and Labs.

The position will support multiple production functions (from Quality operations to Quality Engineering) to achieve site goals while providing Quality oversight and ensuring compliance. Supporting resolution of potential nonconformance events by applying the deviation and CAPA management procedure in conjunction with other procedures as applicable to facilitate decision-making with a cross-functional team as needed. Perform other duties as assigned by the management.

This role will require a local presence at the VMC Boston MA site.

Key Knowledge/ Skills and Competencies:

• Strong oral and written communication skills required
• Good Interpersonal skills required
• Attention to detail

Knowledge in the following areas:

• Understanding of global GMP requirements governing oral drug products and knowledge of oral drug product manufacturing practices

Oversight of Internal Operations QA Operation and Compliance

• Act as a first point of contact in case of QA support for shipping and material transfer.
• Ensure regular presence in GMP operations areas as needed. Performs Line and area clearance.
• Responsible for raw material release.
• Review and approve batch production records and other GMP documentation in support of daily operations.
• Generate performance metrics trends; including site metrics for investigation/CAPA Equipment and Facility Change Controls etc
• Participate in self-led inspections and provide support during internal/external regulatory inspections.
• Responsible for identifying risks and communicating gaps for GMP process/systems
• Support Lean Transformation and Operational Excellence initiatives
• Adhering to safety rules and maintaining a safe work environment for both you and others by supporting EHSS corporate and site goals

Oversight of Internal Operations Quality Engineering

• Provide Quality oversight and review of calibrations PMs eCRs work orders and laboratory operations via instrument qualifications
• Support EM and UM programs and control programs
• Provide support for facilities and engineering projects including capital projects annual plant shutdowns and various improvement projects as assigned

Audit / Inspection Support

• Participate in inspection readiness activities and provide support during regulatory site inspections. Provide post-inspection support to address any regulatory observations.

Deployment of QMS and Establishment of Compliance Expectations

• Participate in process improvement initiatives (as necessary) performing gap analysis and risk communication.
• Act as a trusted advisor to the site by providing compliance guidance through collaborative review and working with the business owners to gain a better understanding of their needs and facilitate the resolution of quality issues in a timely manner.

Individual Development and Training

• Responsible for timely completion of trainings (100% on-time) goal development self-evaluation and IDP

Minimum Qualifications:

• M.S in life sciences (or equivalent degree) or
• B.S in life sciences (or equivalent degree) and 1-3 years of relevant work experience
• Ability to thrive in a high throughput environment.

Preferred Qualifications:

• Affinity with digital innovation data sciences and Quality engineering
• Experience with raw material receipt and release inspection & sampling
• Highly effective verbal and written communication skills strong interpersonal skills
• Great attention to detail and high degree of accuracy in task execution and GMP documentation
• Ability to providing updates to senior management and identifying potential issues
• Strong organizational skills including ability to follow assignments through to completion
• Knowledge of ASTM E2500 CSV/GAMP and other associated standards is a plus

In this On-Site designated role you will work five days per week on-site with ad hoc flexibility.

Note: The Flex status for this position is subject to Vertexs Policy on Flex @ Vertex Program and may be changed at any time.

Pay Range:

Disclosure Statement:

The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors including skills competencies experience and other job-related factors permitted by law.

At Vertex our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career financial family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter) educational assistance programs including student loan repayment a generous commuting subsidy matching charitable donations 401(k) and so much more.

Flex Designation:

Flex Eligibility Status:

In this On-Site designated role you will work five days per week on-site with ad hoc flexibility.

Note: The Flex status for this position is subject to Vertexs Policy on Flex @ Vertex Program and may be changed at any time.

#LI-Onsite

Company Information

Vertex is a global biotechnology company that invests in scientific innovation.

Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a persons race color sex gender identity or expression age religion national origin ancestry ethnicity disability veteran status genetic information sexual orientation marital status or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities in accordance with applicable law.

Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager or contact Talent Acquisition at

Required Experience:

IC