Quality Specialist Packaging and labeling - New Brunswick, NJ
Quality Specialist Packaging and labeling - New Brunswick, NJ
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$ 83900 - 101700
1 Vacancy
Job Description
ATTENTION MILITARY AFFILIATED JOB SEEKERS- Our organization works with partner companies to source qualified talent for their open roles. The following position is available toVeterans Transitioning Military National Guard and Reserve Members Military Spouses Wounded Warriors and their Caregivers. If you have the required skill set education requirements and experience please click the submit button and follow the next steps. Unless specifically stated otherwise this role is On-Site at the location detailed in the job post.
Challenging. Meaningful. Life-changing. Those arent words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here uniquely interesting work happens every day in every department. From optimizing a production line to the latest breakthroughs in cell therapy this is work that transforms the lives of patients and the careers of those who do it. Youll get the chance to grow and thrive through opportunities uncommon in scale and scope alongside high-achieving teams. Take your career farther than you thought possible.
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.
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 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.
Additional Qualifications/Responsibilities
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 systems such as SAP Veeva or similar and other enterprise systems highly desirable.
The starting compensation for this job is a range from US-NJ-$83900-$101700 plus incentive cash and stock opportunities (based on eligibility).
The starting pay rate takes into account characteristics of the job such as required skills and where the job is performed.
Final individual compensation will be decided based on demonstrated experience.
Required Experience:
Unclear Seniority
Employment Type
Full Time
