Specialist, Right to Operate

Foundation Medicine, Inc.; Morrisville (NC); On-site; USD 64,000 - 106,000; Full time

Job summary

Foundation Medicine, Inc. in Boston, MA is seeking a Right to Operate Specialist to support the Clinical Laboratory in complying with state, local and federal regulations and internal policies.

This role collaborates cross-functionally to support client requests and audit responses. Responsibilities include maintaining staff training records, supporting QA during external audits and CAPA, reviewing competency forms and ensuring adherence to CLIA, CAP, MA, and NY state regulations, with travel up

Qualifications

• Bachelors Degree in Biology, Chemistry, or life science field.
• 4+ years of experience in pharmaceutical/biotech/diagnostic industries.
• 3+ years of GMP/GLP/GCP experience.

Responsibilities

• Maintain lab operation staff training/personnel files.
• Support QA in documentation and external audit requests.
• Follow company policies and applicable procedures.
• Adhere to CLIA, CAP, MA, NY state regulations.
• Act as a laboratory operations liaison to internal customers.
• Review competency assessment forms and KPI metrics.

Skills

HIPAA knowledge

Audit experience

Attention to detail

Communication skills

Education

Bachelor's Degree in Biology, Chemistry, or other Life Science field

Job description

Foundation Medicine, Inc.

Specialist, Right to Operate

• 400 Summer Street, Boston, Massachusetts, United States
• Full Time

About the Job:

TheRight to Operate Specialist is responsible for supporting the Clinical Laboratory in adhering to state, local and federal regulations as well as internal policies and procedures. The position applies regulatory knowledge in fulfilling their job responsibilities and collaborates cross functionally to support client requests and follow up during onsite audits.

Key Responsibilities:

• Maintain lab operation staff training/personnel files.
• Support Quality Assurance in the procurement of documentation and fulfillment of requests for external audits.
• Follow company policies and applicable procedures.
• Execute work with adherence to GCP requirements and applicable regulations, including, but not limited to, CLIA, CAP, MA state, NY state.
• Act as a laboratory operations liaison to internal customers.
• Review competency assessment forms and ensure competency assessments are completed on time; maintain, monitor and report on competency assessment KPI and metrics.
• Assist with Non-Conformance Report generation, review and trending.
• Partner with the Laboratory Operations Management team in creation and review of Quality documents.
• Respond to audit findings and coordinate the completion of response plans.
• Support the continuous improvement of laboratory processes.
• Support the Quality Assurance Internal Audit Program.
• Support laboratory operations CAPA program.
• Support external and internal proficiency programs including report writing.
• Maintain availability to work outside of a regularly scheduled shift.
• Travel domestically up to 10% of the time.
• Other projects as periodically assigned.
• Comply with FMI's attendance policies

Qualifications:

Basic Qualifications:

• Bachelors Degree in Biology, Chemistry, or other Life Science field
• 4+ years of experience in the pharmaceutical, biotechnology, medical device or diagnostic industries
• 3+ years of experience with GMP, GLP or GCP processes

Preferred Qualifications:

• Prior experience with supplier/vendor management
• Experience with internal/external audit
• Experience with process validation
• Able to work well under pressure while maintaining a professional demeanor
• Able to prioritize and thoroughly follow up on assigned tasks
• Able to handle multiple tasks at once and work in a fast-paced environment
• Able to adapt to changing procedures, policies and work environment
• Detail-oriented, organized and able to shift priorities based upon business needs
• Excellent communication skills to effectively collaborate cross functionally
• Understanding of HIPAA and the importance of patient data privacy
• Commitment to reflect FMIs values: Integrity, Courage, and Passion

The expected salary range for this position based on the primary location of Boston, MA is $84,800 - $106,000 per year. The salary range is commensurate with Foundation Medicines compensation practice and considers factors including, but not limited to, education, training, experience, external market conditions, criticality of role, and internal equity. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for Foundation Medicine's benefits.