Company Description
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.
Job Description
The QC Laboratory Manager ensures quality control and environmental control compliance across the manufacturing site. Create and implement environmental programs and policies, oversee the organization's environmental performance, and ensure the organization is complying with regulations and requirements of environmental control policies. Ensures quality environmental requirements are achieved.
Responsibilities
Manage micro laboratory operations and ensure compliance with regulations including EU Annex 1, ISO, WHO, FDA Guidelines for Aseptic Processing, among others. Ensure robustness and approve Investigations Microbiology EM.
In charge of MEC laboratory operations for in-process, finished product, microbiological testing of raw materials, USP water, and cleaning samples.
Develop strategies to ensure the environmental training for staff at all levels is aligned with regulations. Review and approve environmental control strategies outlined for manufacturing facilities. Primary review and approval of microbiological recoveries Exception Report (ER) investigation, writing, review, and ensuring effective CAPAs. Facility qualification and validation protocol review, and approval.
Responsible for the data trending and reports generation (monthly and quarterly trend reports) to ensure the actions are taken proactively and timely to minimize events in the Lab and Manufacturing areas.
Lead a multidisciplinary high-skill team focusing on laboratory controls or environment controls within aseptic processing areas, in-process and release test in a 24/5 operations. Develop strategies to meet targets and to encourage best practices by selecting the best tools and systems to monitor EM performance.
Assure that existing laboratory methodology is maintained within AbbVie guidelines. Interfaces with other AbbVie groups to build collaboration and harmonization within the development and manufacturing AbbVie network. Participate in multidisciplinary teams across the AbbVie sites and in Micro Center of Excellence.
Participates in the evaluation of laboratory events and ensures that excursions associated to laboratory OOS, etc. are investigated, resolved, and documented on the exception report system. Impalement corrective and preventive actions to avoid the occurrence and recurrence of events and that no materials are released before the completion of the investigation.
Responsible of elevating to the appropriate levels of management within Quality Operations Senior Management of significant quality issues in a timely fashion. Reviews and approves laboratory instrumentation, utilities, and facilities qualification and labs system life cycle documentation.
Assure fulfillment of environmental, health, and safety (EHS) requirements and compliance obligations, promote continuous improvement, and consider EHS aspects during the design and change process.
Qualifications
Bachelor's degree in Science required. A microbiology major is strongly preferred. Master's Degree prefer.
Eight (8) years of experience in microbiology laboratories, or related functions, in the pharmaceutical industry. Must be able to utilize statistical quality tools. Must possess sound technical, and quality judgment especially when acting on issues when time is of the essence.
At least five (5) years of experience managing direct reports.
Must possess a high degree of integrity and demonstrate capability of making critical evaluations which are essential to the identification and resolution of quality problems.
Excellent verbal and written communication in both English and Spanish.
Computer literate including but not limited to Microsoft Office (Excel, PowerPoint, Word).
Capable of handling multiple priorities.
Strong Problem-solving skills. Strategic and negotiation skills. Strong Interpersonal and leadership skills.
Additional Information
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
This job is eligible to participate in our short-term incentive programs.
This job is eligible to participate in our long-term incentive programs
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law.
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVie's policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.
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US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
https://www.abbvie.com/join-us/reasonable-accommodations.html
