Senior Specialist, QA Shop Floor

Bristol Myers Squibb•Summit, NJ

4d•$83,900 - $101,671•Onsite

About The Position

The Quality Assurance Shop Floor team is responsible for 24x7 Quality collaboration and oversight of site operations, including but not limited to Manufacturing, Quality Control Laboratories, Label Operations and Warehouse Operations. This position will oversee and partner with operational areas to ensure compliance with Bristol-Myers Squibb policies, standards, procedures, and Global cGMP.

Requirements

Ability to research, understand, interpret and apply internal policies and regulatory guidelines.
Proficient computer skills with knowledge of digital tools such as MS Office, etc. and ability to learn and work with new software applications.
Ability to interpret data & results, understand complex problems with multiple variables, and articulate practical solutions.
Excellent written and verbal skills and ability to present technical data effectively based on target audience.
Ability to work in a fast-paced team environment and lead peers through changing priorities.
Detail oriented and task focused with ability to meet deadlines and support work prioritization.
Ability to negotiate and influence to craft mutually beneficial solutions.
Ability to motivate and foster a positive team environment.
Exhibit strong decision-making ability and think creatively while maintaining compliance and quality.
Pioneering mindset and ability to create innovative solutions.
Bachelor's degree in STEM field preferred. High school diploma/ Associates degree with equivalent combination of education and work experience may be considered.
4+ years of relevant cGMP experience, preferably with 1+ years of manufacturing site experience.
Experience in FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing is preferred.
Demonstrated experience with quality management systems
Demonstrated experience with electronic systems and databases such as Manufacturing Execution systems (MES), Enterprise Resource Planning (ERP), etc.

Nice To Haves

Experience in FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing is preferred.

Responsibilities

Provide Quality on-the-floor oversight to Manufacturing/QC/Warehouse/ Packout operations/Label Operations.
Identify departures from approved procedures and respond to complex issues independently and escalating critical issues to management.
May perform and document operational verification per approved procedures.
Develops, reviews and/ or approves temporary and non-routine procedure for event response.
Observe manufacturing operations and identify departures from clean room behaviors and aseptic techniques.
Provide quality oversight to non-routine maintenance work. Review and approve return to service plans.
Coordinate and lead area walkthroughs to identify quality issues. Negotiate remediations and drive alignment of implementation plans.
Own shift actions for departmental programs and propose improvements to programs.
Participate in Gemba walks.
Review manufacturing or testing records to ensure compliance with approved procedures. Communicate and resolve discrepancies independently and escalate as required.
Author, review, and approve procedural documents.
Maintain compliance with assigned learning plan. Provide guidance and training for QA personnel.
May own training curriculum and content.
May present individual topics during audits as needed.
Independently assess discrepancies for entry into quality system and approve deviations as applicable.
May serve as quality subject matter expert for risk assessments, change controls, etc.
Lead meetings and represent function at cross functional meetings.
Share data/knowledge within and across team. Build & maintain strong relationships with partner functions.
May prioritize and assign tasks for the team.
For markets requiring an Authorized Person (AP) release to be performed by Summit, act as designated AP performing Certification/Release for Supply in accordance with the PIC/S Guide to GMP (including Annex 16) and any local market requirements e.g. Australian Therapeutic Goods Administration (TGA) requirements, including the Therapeutic Goods Act 1989 and associated GMP principles.
Perform verification and reconciliation of issued drug product labels.

Benefits

wellbeing support
retirement and financial protection benefits
insurance offerings (medical, dental, vision, life and disability)
Flexible Time Off (FTO)
11 paid company holidays
160 hours of paid vacation annually for new hires
3 optional holidays
paid sick leave
up to two paid volunteer days per year
summer hours flexibility
leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs
annual Global Shutdown between Christmas Day and New Year's Day