Senior Quality Assurance Specialist

TalentBurst•Pittsburgh, PA

3d•Onsite

About The Position

The Senior Quality Assurance Specialist will support GMP quality activities for a client program in an onsite Cambridge, Massachusetts role. The position is a six-month contract with the possibility of extension. Responsibilities include reviewing event documentation and production records, making product disposition decisions, supporting design development and design history file deliverables, and building and maintaining Product Specification Files. The work covers drug substance, drug product, device assembly, and finished goods. The ideal candidate brings pharmaceutical quality assurance experience in a GMP manufacturing and supply chain environment, strong quality dispositioning and exception-management experience, and familiarity with applicable regulations and quality systems. Veeva is preferred; TrackWise or another QMS is also relevant. The role calls for a collaborative, trainable professional who can work independently, prioritize effectively, address complex issues, and get up to speed quickly with limited ramp-up time. TalentBurst describes itself as an equal opportunity employer committed to an inclusive and diverse workforce. It advertises competitive compensation and comprehensive benefits, including medical, dental, vision, and retirement options.

Requirements

At least five years of pharmaceutical quality assurance experience in a GMP manufacturing and supply chain environment; six years is preferred, and candidates with five exceptionally strong years of directly relevant experience may be considered.
Strong quality dispositioning experience; the ideal candidate profile indicates approximately six to nine years of relevant experience.
Knowledge of relevant government regulations and agency rules for labeling, including CFR and EudraLex Volume 4, Annex 13.
Understanding of ICH, GLP, CGMP, GxP regulations, and current industry practices.
Good understanding of FDA and EMA regulations and guidelines.
Experience with exception management.
Ability to prioritize, work independently with minimal supervision, determine deadlines accurately, and ask for help when needed.
Ability to analyze and reconcile moderate to complex issues independently; strong attention to detail and problem-solving skills.
Demonstrated teamwork, initiative, accountability, organization, and ability to work in a fast-paced environment.
Excellent verbal and written communication and interpersonal skills.
Computer proficiency, including basic Microsoft Office and word-processing skills.
The posting lists a minimum BS degree in life sciences, engineering, or a related field, while its ideal-candidate profile says a bachelor's degree is preferred and candidates with an associate degree may be considered based on relevant experience.

Nice To Haves

Veeva QMS proficiency; experience with TrackWise or another QMS is also relevant.
Experience with temperature excursions and Veeva Tasks.
A Lean mindset and a collaborative approach, including working with Clinical Supply Chain.
Smartsheet experience; basic proficiency is sufficient.
A master's degree or PhD is welcome; candidates with an associate degree may be considered based on relevant experience.

Responsibilities

Review event documentation, including batch records, exceptions, and regulatory filings.
Review production records and determine product disposition for drug substance, drug product, device assembly, and finished goods.
Support design development plans, including design verification and design history file (DHF) deliverables.
Build and maintain Product Specification Files (PSF) for the client program.
Initiate and manage files in Veeva, as applicable.
Collaborate with the team, including Clinical Supply Chain, and get up to speed quickly with limited ramp-up time.