Deviations Specialist

Arcadis; Boston (MA); On-site; USD 80,000 - 100,000; Full time

Benefits offered by this job

Medical benefits

Dental and vision insurance

401K

Paid parental leave

Tuition reimbursement

Job summary

Arcadis is seeking a Deviations Specialist in Boston, MA, to lead and manage deviations and investigations within the pharmaceutical sector. The role demands collaboration with various functions, emphasizing on-time closure of deviations to support product delivery.

The ideal candidate will have a background in a scientific discipline, excellent communication skills, and a strong attention to detail. The position also offers a range of benefits, including medical, dental, vision, and generous PTO.

Qualifications

• Experience in the pharmaceutical/biotech industry.
• Ability to interact with regulatory authorities.
• Experience working in electronic Quality Management System.

Responsibilities

• Lead deviations and investigations for the client.
• Document impact assessments and lead RCA.
• Ensure On-Time Closure of Deviations for Batch-on-Time-Delivery.

Skills

Excellent verbal and written communication skills

Attention to detail

Ability to work collaboratively across functions

Knowledge of global regulations and standards

Strong team player

Education

Bachelors or Advanced degree in a scientific discipline

Job description

Summary

Arcadis is seeking a Deviations Specialist for a client in Boston, MA.

Responsibilities

• Lead, write and review deviations and investigations for the client, including the manufacturing, facilities, supply chain/materials management and support QC deviations as necessary.
• Identify and assemble proper SMEs for triage, determine immediate actions taken, document impact assessments, lead RCA, develop appropriate CAPAs.
• Strong knowledge of cGMP requirements for manufacturing.
• Experience working in electronic Quality Management System.
• Demonstrated understanding of the principles and applications associated with cell and gene manufacturing operations, maintenance/calibration, engineering, and validation.
• Deliver On‑Time Closure of Deviations to support Batch‑On‑Time‑Delivery commitments for Tech Transfer – New Product Introduction, Clinical, and Commercial Products.
• Other duties as assigned.

Skills and Qualifications

• Bachelors or Advanced degree in a scientific discipline.
• Experience in the pharmaceutical/biotech industry in combination with drug substance/drug product manufacture, development and/or quality.
• Excellent verbal and written communication skills, detail‑oriented personality, and ability to work collaboratively across functions.
• Experience interacting with regulatory health authorities inspections.
• Knowledge of global regulations and standards.
• Strong team player that has a customer service approach and is solution oriented.
• Attention to detail and the ability to work individually as well as within a multi‑disciplinary team.
• Excellent listening, communication and interpersonal skills fostering team spirit.
• Consistent delivery of high‑quality work at all times.
• Ability to gown and work in a cleanroom environment.
• Ability to provide legal US work authorization documents required. Will consider US domestic travelers and relocation.

Benefits

Arcadis offers benefits for full time and part time positions. These benefits include medical, dental, and vision, EAP, 401K, STD, LTD, AD&D, life insurance, paid parental leave, reward & recognition program and optional benefits including wellbeing benefits, adoption assistance and tuition reimbursement. We offer nine paid holidays and 15 days PTO that accrue per year. Salaries will vary and are based on several factors, such as experience, education, budget, internal equity, project and location.

Equal Opportunity Employer

We are an equal opportunity and affirmative action employer. Women, minorities, people with disabilities and veterans are strongly encouraged to apply. We are dedicated to a policy of non‑discrimination in employment on any basis including race, creed, color, religion, national origin, sex, age, disability, marital status, sexual orientation, gender identity, citizenship status, disability, veteran status, or any other basis prohibited by law.