Job Details
Quality Control Manager 3rd Shift
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.
***3rd SHIFT Mo-Fri. 10pm - 6:30am***
Education -Knowledge/Skill requirements:
BS in Biochemistry or Chemistry
5 years of supervisory experience within the Analytical laboratory in the pharmaceutical industry
Experience with bio-analytical techniques as SDS PAGE, IEF, SEC, ELISA, CE, cell culture, bioassays, etc.
Experience with analytical techniques as HPLC, GC, UV, IR, etc. preferable
Deep technical knowledge of proteins and bio-molecules handling and analysis.
Active in PR Chemical Association License is required.
Excellent Communication skills – English / Spanish (oral and written).
Proficient in the use of financial and quantitative information to develop realistic budgets and central operational expenses.
Posses up to date knowledge in the profession and industry.
Strong knowledge in fundamental, practical and theoretical understanding of biochemistry.
Working knowledge of business, PCs and related software's.
Proficiency in troubleshooting laboratory equipment and analytical and bio-analytical methods.
In depth knowledge of compendia applicable to pharmaceutical analytical methods.
Knowledge of EHS policies, procedures and regulatory requirements.
Knowledge of the regulatory requirements governing the functions of the analytical testing laboratory for pharmaceutical products.
Knowledge of applicable testing compendia (foreign / domestic).
Practical knowledge of laboratory instrumentation (HPLC’s, UV’s, GC’s, FTIR, AA, NIR)
Accomplishments in the areas of innovation, teamwork, personnel and leadership development, customer services.
Understanding of the business from the local and global perspective.
Responsibilities:
Establishes short and long range plans for the timely and efficient execution of the analytical testing activities within the scope of the business priorities and applicable regulatory requirements (FDA, DEA, OSHA, Police Department, PR Chemical Association).
Develops mechanisms and structures to allow for adjustment in the laboratory testing schedule to meet changing priorities due to business needs.
Implements systems to lead, guide and motivate the personnel under his / her responsibility to perform at the maximum potential.
Encourages and facilitates the willingness to accept more responsibilities to develop their potential to a greater degree.
Performs timely and effective staffing related activities including, but not limited to the requirements of the Human Resources policies and procedures, hiring / termination, recognition / disciplinary actions, performance appraisals and; assures that all Bio analytical personnel are qualified and trained in the applicable procedure required for their jobs functions.
Fosters cycle time reduction initiatives within the scope of the Continuous Innovation approach.
Ensures that the laboratory operates within the budget commitments.
Reviews and makes disposition of laboratory records ensuring that the analytical data complies with requirements / specifications.
Identifies, unusual analytical test results / trends. Conduct trend analysis.
Consults R & D, Analytical Development Group and other departments for resolution of technical and operational issues.
Communicates with internal and external customers.
Coordinates samples testing and analytical reports disposition.
Designs experiments (where applicable) as part of laboratory investigations.
Organizes and plan individual and collective work.
Assures completion of investigations and completeness of analytical data for lots / materials disposition.
Anticipates problems / situations and develop plans to prevent or minimize impact. Use internal and multifunctional teams, as appropriate.
Uses the technical knowledge and experience from self and team members to systematically gather and analyze data in an efficient manner to draw logical conclusions. Exercise analytical and strategic thinking.
Assists the Analytical Labs Manager in the administration of:
a. Budget
b. Lab. Performance Metrics
c. Lab. Supplies inventories
d. Report CAR’s
e. Company initiatives / special projects
f. Foster leadership, growth and continuous innovation initiatives at all levels.
Establishes and ensures and effective process / system for disposition of raw materials, API’s, finished products, packaging and labeling materials.
Ensures that all Quality Control (QC) personnel involved in testing of finished products, API’s, biological drug substances, raw materials, intermediates / components have approved, validated methods and specifications, robust systems and adequate facilities to perform required testing. Ensure all necessary testing is carried out.
Assures that the QC equipment and personnel are formally qualified before release testing of products/materials is performed.
Uses results of testing performed in the Incoming Materials Area, Analytical and Microbiological laboratories for the disposition of products and / or raw materials.
Assures that stability studies performed at the site follow specific protocols and procedures.
Ensures that stability data supports the retest /expiry date and storage conditions of the product and that a system is in place to assure trending of data for any anomalies.
Ensures the functional area has an effective process /system for disposition of raw materials, API’s, packaging and labeling materials.
Completes functional Annual Product Quality Review Report elements as established in products / systems schedule.
Ensures that the functional area has an effective process in place for reserve sample collection and storage.
Verifies consistency with other site procedures and/or specifications.
Verifies compliance with BMS Policies and Guidelines.
BMSBL
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.
Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.
To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.
Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
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