Quality Compliance Specialist
• Investigates customer complaints, external complaints conduct Internal Audits, approve regulatory CAPA, Vendor Certification, Quality Agreements, Annual Product Review / Report for Finished Product and Systems and site licenses.
• Supports readiness of the facility for Regulatory Inspection. Assists the Associate Director Compliance and auditing during regulatory agencies inspections such as FDA / EMEA and/or during internal company audits. Documents any FDA communication between Site and agency.
• Conducts internal / external audits following annual site plan with respective reports and actions items from areas impacted during the audit.
• Prepares, submit and discuss reports of assigned Quality Systems status for trending and evaluation to the site management.
• Communicates frequently with management and informs, via frequent written reports, any problem that might affect the quality of the product or the compliance state of the facility.
• Provides site GMP training based on annual requirements and support and training to other departments to ensure quality compliance as needed.
• Assures that site complies with Corporate Systems by evaluating, implementing and enforcing the company policies and guidelines.
• Aligns facility Quality Systems with GMP’s, Regulatory Standards and domestic and international markets requirements.
• Maintains communication with internal and external customers to ensure compliance and timely completio
ProsExempt employee, professional comunication, good relations with the others people.
ConsDistance to drive
3.0
Customer Service Representative | Princeton, NJ | Nov 19, 2013
Early on as in within the first 4 years everything was great with perks bonuses and incentives and then since its felt like a foreign sweat shop.
Well we laugh and joke around with our fellow co-workers and reminisce and most of us are happy people by nature so that's what keeps us going but as for everyone else you can tell they're stressed out and hate whats become of the company but I guess they feel like they have no choice due to their ages and lack of talent or physical capabilities...Of all the people that are still here they're only 3 others with the drive, passion and talent to make any company pertaining to design and printing thrive. I'm positive they will leave if an opportunity presents itself...We love to think of ourselves as The A-Team.
As for what I've learned well when it comes to printing everything I've learned is because of my drive to be better at everything I do and having the opportunity to do so while being an employee here...Microsoft Office and Adobe for MAC and Windows is what I learned here over the past 10 years working hands on with in my spare time and learning on the job due to dealing with electronic files 98% of the time since I started working here but I do occasionally work from hard copies that need to be scanned for records keeping which is something we started doing here a lot lately.
My manager is amazing but his hands are tied most of the time with getting the necessary equipment to make us more efficient so we have to do what we can with the primitive equipment we have...I'm a person that's intrigued with technology and try to push for anything that comes out to make us
ProsDoing what you love and feeling like you're around family.
I am a results-oriented leader with a proven record of achieving objectives in a Fortune 500 environment, and a highly effective project manager with experience leading multi-functional teams in both a direct and indirect leadership role. Excellent technical and analytical skills, organized with strong attention to detail and deadlines. Demonstrated ability working at all levels within an organization including effective interaction with executive management.
I have extensive Bio-Pharma experience working in the SAP space as the overall managing director accountable for project deliverables executing on all SDLC phases while incorporating Global legacy systems master data into SAP since 1997 and building master data governance solutions on top of SAP. Although I left BMS as a Director of Corp IT, I have worked at many levels and can work as a project manager or lead enterprise 'data' projects.
I led 3 Data Services affiliated with SAP: 1. Data Migration services with 12-15 projects running simultaneously, 2. Active Data Governance Bolt-On solutions for both Material Master data and Financial data and 3. Electronic Data Archiving solutions.
I founded BMS’ Data Migration Competency Ctr. and built it from the ground up. I expanded the DMCC to also include Data Governance and Data Archiving solutions. Prior to starting the DMCC, I managed the SAP Sales & Distribution team and have many years of SAP experience building interfaces and migrating data in and out or both R/
ProsGreat benefits, international travel, cures for cancer via R&D
Bristol-Myers is one of the better companies that I have worked for. The benefits are generous, most employees are nice, and the company makes a conscious effort to keep employees engaged and focused on the company mission.
Management within a particular group is another story. Many of the managers have little to no leadership skills. They would likely not be managers in NJ or at another company. There are some areas who are focused on promoting from within their group, even though those selected are not qualified for the role.
People were pushed out or fired for not getting along with the right people. The reasons used to fire those people could have been applied to at least 2 or 3 others in the group, but because rules are applied selectively, only a few were fired and had their careers impacted.
There is a noticeable disparity in workload per associate. Some associates work tirelessly, and have no work life balance. Others barely work 35-40 hours per week, and spend their days on social media, scrolling through their phones, or chatting and walking around. In other companies, management would take notice of this and make an effort to balance the workload, or push out those who don't perform. Others were given impossible workloads, with no support and then subsequently fired for not performing.
Knowledge gained is limited because most of the managers are not strong and don't have the skills needed to impart knowledge to their direct reports.
Growth opport
Driven, fast-paced research environment with diverse experiences
Most researchers for BMS are mid-career professionals with years of experience. As a twenty year old, it can sometimes be difficult to make friends since the average age is so large. A typical day of work is either meetings, novel research topics, vendors, and presentations or focused research and infrastructure work. The hardest part of the job is the tendency for the company to want to differentiate itself and its software infrastructure from competitors and simplify the experience of complex theoretical or analytical techniques for ease of use, which leads to assumptions. I learned the emphasis placed on documentation and clean UI, though I prefer to generate scientific command-line interfaces over web interfaces. The most enjoyable part of the job is the banter and conversations at lunch I had with my groups, I found it fulfilling and satisfying to keep the group together, though it always feels like people are talking over my head instead of talking directly or being friendly. Maybe there's something socially awkward about scientists to begin with. The management is strong and firm with its deadlines and expectations are expectedly high in a post-grad bleeding edge organization supporting urgent medical needs. It's a tough company.
ProsGreat cafeteria, some troubleshooting and educational resources, HPC, excellent IT support
Cons9-to-5 mentality, worker burnout and heavy load, majority are PhDs in the groups I was in who have forgotten how rough their starts were.
A pharmaceutiical with a good Biotech products in the pipeline
I usually reach the plant at 6:30 to 7:00am . Read the E-mails first to know how the manufacturing process run overnight. Based on the mfg.needs, product transfer needs and on the re-qualification schedule, coordinate the technical support needed from my area to facilitate either the manufacturing operations or the activities to continue product transferring.
Review the pending items that requires my supervision or scientific feedback to coordinate meeting for discussion.
Review, comment and approve Investigations, Change Controls, CAPAS and Non-conformaces. If some of the previously mentioned items lack of any key elements I consider necessary for my approval, a meeting is called to discuss my comments and provide the scientific and or compliance response. Between meetings, visit to the manufacturing areas to evaluate situations, reviews, comments ,approvals of documentation, generation of a scientific report to support anyone of the the Quality systems in place, workload coordination of the area, and feedback to the group, I always tend to leave the plant from 7:00 to 9:00pm. Exhausted!!! But the most enjoyable part of the job is the people in the plant,all are so nice, friendly and willing to help that is gratified to work so hard.
ProsProducts in the pipeline and people
ConsShort of personnel in the plant creates an overload of work becaming the hardest part of the job.
4.0
Senior Sales Executive | Princeton, NJ | Oct 2, 2018
BMS Review
Bristol Myers-Squibb was a great company to work for. It offered a great deal of benefit to their employees. In the time that I was at the company, I was able to utilize computer/application skills that I wasn't able to any other companies. Although I used Microsoft products most of the time, in other company, the level of expertise in Excel and Access gave me greater opportunities to formulate and distribute reports quickly.
The company promoted team building as well as discussions to make things better. It encourages employees to offer solutions to operating procedures that could be done better.
Another nice thing about BMS is that it is a strict encourager of volunteering services and I had the greatest opportunities to participate in providing school supplies for underprivileged students, working with United Way to provide reading kits to children in hospitals in the community, and also to provide Christmas/ Hannakah gifts that were given to children around the holidays.
They matched our 401K contributions up to a certain amount of money, they help with having a Childcare service right on the premesis and an onsite cafeteria. We also had the benefit of having vendors ranging from farmers' markets to expensive jewelry and clothing.
I got to work alongside a lot of nice and professional individuals.
On a daily I worked with one other partner to promote cardiovascular, diabetes, and anti-hypertensive products. I covered a vast territory spreading from Rome, GA to the TN border then rural locations like Blue Ridge, Ellijay, Jasper, and Blairsville. I developed a business plan it help ignite market share. I was part of a launch of a new oral diabetes product called Onglyza. It was the first of it's kind and very exciting to offer physicians and patients an new way to help them with their diabetes. I created a 2 week routing with my sales partner to ensure all our customer and most highly valued customers were seen each week and some seen more than once per week. I grew market share with several products even with challenging managed care situations, I was consistently given project deadlines and they were always met through my effective time management and organization. I partnered and mentored others through my region to share best practices with them to help them be more successful. I completed all training in a timely manner with exceedingly high marks.
ProsVery corporate comapny but valued their employees performance, dedication, and loyalty to the company. I had constant re-assurance and posivity from all levels of management, even from my direct manager to the CEO.
I have worked for Bristol- Meyers for many years now. Bristol- Myers is a great company to work for they have great benefits and descent pay. However Management at the Redwood City campus has drastically changed and has taken a turn for the worst. This is a company that I used to have pride in working for but the culture of this company has now changed. Management is very critical, negative and demeaning to their employees. They micro manage staff. Staff members used to be able to speak freely of how they feel and now are look down upon and treated as "bottom feeders" rather than equals. Management also is very double standard and are not held to the same accountability as other staff members. Many employees have left within the last 6 months. I hope that Administration back in New Jersey starts to see the trend of employees who have left and see the high turn over that is now taking place. This is NOT a company I would recommend working for any longer. Most employees who are still here are trying to find work elsewhere. I am not saying this because I am jaded by the management I say this as a warning to anyone looking to come on staff with BM Redwood city only. I love the company what they stand for and what they believe in but I do not agree with how management and the leaders are leading this team.
Solid company, many benefits, opportunities for advancement - no work/life/balance
Fast paced, stressful work environment but many opportunities for growth within the organization to learn and show case talents
In addition to daily responsibilities, projects are also assigned. These projects are extremely time consuming with very tight deadlines. In many instances there are constraints on deliverables due to companies reliance on selected outsourced providers/partners performance.
The company values work/life balance but needs to further implement steps to ensure employees have the opportunity to participate. As with other companies, BMS has reduced the workforce to bare minimum without a reduction in the workload.
BMS is always on the leading edge of technology. The organization continuously reviews and revisits processes to ensure they are compliant and streamlined. Best practices are implemented. This is accomplished through technology and also by benchmarking with other companies (both pharmaceutical and non-pharmaceutical)
ProsLeading edge technology, Opportunities for growth, Exposure to many groups
ConsNo work life balance, Excessive offshore outsourcing, Providers/Partners are not qualified to perform tasks, High turn over rate in these positions leading to repetitive training of resources
Bristol-Myers Squibb: É uma empresa com um bom ambiente de trabalho com profissionais bem preparados, qualificados e capacitados.
A atualmente a direção é jovem e isto tem um impacto na forma de liderar falta maturidade para olhar para os seus colaboradoes/profissionais com suas especificas particulares e qualificações. Aprendi acreditar nas mudanças, efetivamente ser ética sempre, acreditar na missão da empresa, ser comprometida com a pessoas que estão sob a minha responsabilidade/gestão e ser sempre uma pessoa do bem e para o bem.
Parte dificil do trabalho lidar com a vaidade das pessoas e falta de transparência.
Parte agradével atuar em pesquisa clínica, ter os colegas profissionais hoje, como referência profissional.
RPS/Sanofi: Uma empresa com pessoas bem preparadas, com interesse no desenvolvimento de seus colaboradores e valorização dos mesmos. Considero a gerência como referência para a continuidade da minha vida profissional.
Dia de trabalho: gerenciar o estudo de uma forma geral, desde a logística até a parte operacional, incluindo resolver assuntos especificos dos centros de pesquisa e adotar planos de ação para atingir objetivos e métricas.
Meus colegas de trabalho são pessoas responsáveis, comprometidas e do bem. Aprendi que independente da experiência (tempo de atuação na área) devemos estar sempre abertos para o aprendizado e para acompanhar as mudanças.
Parte agradável: trabalhar em pesquisa clínica, gerenciar pessoas e conviver com profissionais do "bem".
Pa
Prosvale refeição
Consbeneficios diferentes para pessoas com a mesma função.
Questions And Answers about Bristol-Myers Squibb
What is the interview process like at Bristol Myers Squibb?
Asked Oct 13, 2016
I had to do a phone screen with a talent advisor, then a phone screen with the hiring manager, then a panel plus a technical test. Then they asked for references and now I'm still waiting to hear if I got hired.
Answered Sep 27, 2021
Over the suspension of operations I was contacted by the director to give me more information about the job I applied for and then a month later was contacted by the hiring manager that the director just newly promoted to associate director. We chatted more about the job again. 2 months go by, from initial director phone call and still no formal interview. Mind you the recruiter they have that facilitated this is really poor at her job. She not once confirmed phone calls with me, both phone calls were last minute connections and I had to initiate contact. After the chat with the newly appointed associate director, I was ghosted by everyone in the hiring process. This process gave me a good understanding of how this organization operates. They did me a service by not moving me onto the next process.
Answered Jun 23, 2020
What is the vacation policy like at Bristol Myers Squibb? How many vacation days do you get per year?
Asked Oct 26, 2016
15 days policy
Answered Oct 6, 2017
Vacation policy was fair. Started with two weeks and gradually increased over time.
Answered Jun 16, 2017
How do you feel about going to work each day at Bristol Myers Squibb?
Asked Oct 5, 2016
Good! Is was a good place to work.
Answered Aug 23, 2017
A typical day at work
Answered Jul 31, 2017
How often do raises occur at Bristol Myers Squibb?
Asked Oct 5, 2016
Annual based on job performance
Answered Jun 23, 2017
Raises were granted annually based upon performance of the individual and the company meeting targeted objectives.
Answered Jun 21, 2017
If you were in charge, what would you do to make Bristol Myers Squibb a better place to work?
Asked Mar 10, 2018
Do you have the Salesforce an opportunity to say goals and implement them. Stop the marketing department for making decisions that have no effect on sales
Answered Apr 14, 2020
Stop promoting the employees who are bipolar and have no people skills, drama queens basically. Their Corporate Controller creates drama everywhere she goes
