QC Operations Specialist - Stability

Location: Onsite in Woburn, MA

Length: 8 months (through end of 2025)

Summary:

The client’s Quality Control Stability Program covers starting materials (bacterial and mammalian cell banks, viral banks, and plasmids), drug substance, and drug product. The QC Operations Specialist - Stability supports early and late-phase clinical and commercial shelf-life setting and meet global regulatory expectations across a multi-product portfolio. The QC Operations Specialist – Stability will provide significant contribution to daily operations as detailed below. This position requires partnering with various internal laboratory operations as well as a Contract Testing Organizations (CTO) network. This role will report to the Director, Quality Control Operations -Stability.

Duties/Responsibilities:

Contribute to the operation and execution of stability programs across a multi-product portfolio.

Originate ICH compliant stability plans, protocols, and reports; coordinate, review, trend, and report stability test data for starting materials (bacterial and mammalian cell banks, viral banks, and plasmids), drug substance, and drug product.

Execute day to day operations by receiving and processing stability samples in LIMS; at initiation of study into appropriate chambers and at time of pull and sub-aliquoting sample material for testing within internal laboratories, and/or coordinate shipments of samples to external laboratories.

Manage testing status and data collection from both internal and external laboratories.

Collaborating with Quality, internal functional areas, and internal and external testing laboratories, to review and perform documentation of deviations, CAPAs and OOS/OOT investigation reports.

Upload stability data to LIMS and/or Veeva to generate stability reports.

Utilize statistical software to trend analytical data associated with stability testing.

Ensure all work performed strictly adheres to UGT SOPS and cGMP requirements.

Follow good documentation practices, all safety rules, and regulations.

Qualifications/Requirements:

Associate degree with 4+ years or bachelor’s degree with 2+ years in a scientific discipline with 2 years GMP stability experience preferred

Strong knowledge of cGMP/ICH/FDA/EU stability regulations

Knowledge of aseptic processing and contamination control.

Superb communications—both written and oral skills – and strong interpersonal skills.

Ability to work in a fast-paced matrixed environment.

Strong attention to detail and organizational skills

Ability to drive, and work well, in teams and independently.

Experience with and good understanding of statistical software packages such as JMP, Quality Management Systems such as Veeva, and LIMS systems such as LabVantage, preferred.

Physical Demands/Work Environment/Safety Considerations:

Stand for extended periods of time with periodic stooping/bending / kneeling.

Able to lift, push, pull up to 50lbs.

Climb ladders and stairs of various heights.

Work in a lab environment requiring special protective clothing over the head, face, hands, feet, and body. This role requires the ability to wear personal protective equipment.

Certain tasks may require use of a respirator; medical clearance will be required in advance.