Quality Specialist

Profile

At Bristol Myers Squibb, we are inspired by a single vision - transforming patients' lives through science.In oncology, hematology, immunology and cardiovascular disease - and one of the most diverse and promising pipelines in the industry - each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

Role overview

Title: Quality Specialist, Packaging & Labeling, Warehouse Operations, Distribution Logistics

Report to: Associate Director, Product Development Quality (PDQ) - Packaging & Labeling, Warehouse Operations, Distribution Logistics

Grade level: D05

Location: New Brunswick

# of direct reports: NA

Scope of the role

Provide Quality oversight/support for Product Development Clinical Supply Operations and Clinical Supply Chain.

Performs specific quality related functions such as batch disposition, quality incident investigations, change control, procedural review and GMP/procedural training to ensure compliance with GMP regulations and BMS standards.

Key responsibilities

The position reports to the Associate Director (PDQ) - Packaging & Labeling, Warehouse Operations, Distribution Logistics, with job responsibilities that include but are not limited to:


Reviews, in a timely manner, all batch and test documentation associated with investigational medicinal products (IMPs), and releases those found in compliance into SAP and Veeva® Infinity system as applicable. Responsibilities include the scheduling and planning of work against timelines.
Supports in the investigation of non-conformances and quality incidents. Resolves and documents into Infinity system any deviation or problem pertaining to the audit of documents. Conducts appropriate follow-up, as required. Tracks and trends deviation investigations and CAPAs for Recurrence.
Rejects packaged IMPs that fail compliance to GMP regulations and BMS specifications and requirements.
Ensures records relating to the manufacturing / packaging / testing of IMPs are appropriately archived according to procedures.
May conduct or participate in GMP Training for functional areas supported and provide on-the-job training to new Quality Operations employees, as requested.
Reviews procedural documents, as requested.
Coordinates scheduling/review of records as requested.
Participates in the monitoring program for the P&L and warehouse areas as applicable.
Support internal and/or external audits as requested.
Performs other tasks as requested by the supervisor.
Acts as Authorised Person, responsible for the release of Investigational Medicinal Products in accordance with the requirements laid down in the Australian Government Therapeutic Goods Administration Guidance as necessary as part of supplies release.


Professional experience and qualifications


Knowledge of science generally attained through studies resulting in a B.S., in chemistry, pharmacy or biology or a related pharmaceutical science, with 7-9 years of relevant experience within the pharmaceutical or healthcare industry.
Experience in a R&D environment is highly desirable.
Strong knowledge of pharmaceutical processing.
Strong knowledge of GMP regulations.
Strong interpersonal and organizational skills.
Demonstrated leadership skills.
Knowledge of computer sytems such as SAP, Veeva®, or similar and other enterprise systems highly desirable.


Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.

Company: Bristol-Myers Squibb

Req Number: R1527831_EN

Updated: 2020-07-24 00:00:00.000 UTC

Location: New Brunswick,New Jersey

Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.

Company info

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