Purpose

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. Serves as an integral member of site leadership team with a focus on ensuring quality environmental requirements are achieved.

Responsibilities

• Lead the biologics site micro laboratory process for a high volume, high level of product complexity including multi products to ensure compliance with regulations including EU Annex 1, ISO, WHO, FDA Guidelines for Aseptic Processing, among others. Ensure robustness and approves Investigations Microbiology EM, quality and process excursions or incident.
• Direct MEC laboratory operations such as micro methods for in process, finished product, and stability, 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 skills team focusing on laboratory controls or environment controls within aseptic processing areas, in process and release test. Lead team to support 24/7 on active pharmaceutical ingredients and final drug product. Provide Technical and Scientific leadership, expertise, and guidance by developing strategies to meet targets and to encourage best practice by selecting the best tools and systems to monitor EM performance.
• Assure that existing laboratory methodology at the site is robust and that validation is maintained within AbbVie guidelines. Interfaces with other AbbVie groups to build collaboration and harmonization within the development and manufacturing AbbVie network. Lead and/or participate in multidisciplinary teams across the AbbVie sites and in Micro Center of Excellence.
• Responsible for inspections and regulatory submissions with regards to micro laboratory matters. 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. That corrective and preventive actions are identified and implemented 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.

Significant work activities:

• Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required
• Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required
• Continuous walking for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required
• Frequent to continuous computer usage (greater or equal to 50% of the workday) is required