Quality Manager - Waterbury, United States - Classic Westchester

Description

Responsibilities:
Develop, implement, and monitor aspects of site Quality Management System, including, but not limited to:*site Internal Auditing program*site CAPA program*site Document Control program*site Change Control program*site Deviation Management program*site Continuous Improvement program*Conduct trending of quality eventsCommunicate product issues and deviations to clients, when requiredEnsure a high level of internal and external customer service by responding to customer needs in a timely mannerRespond to CAPAs (site, supplier quality, safety, audits, etc) as assignedRevise or create standard operating proceduresEstablish quality standards, objectives, and goals and communicate to site personnelParticipate in and provide information for regular Quality Management Review Meeting discussionsApproval of specifications, sampling instructions, and test methodsPromote quality achievement and performance improvement across the organizationRespond to or coordinate response to any out of specification reports related to site productEnsure compliance with all applicable regulations and requirementsWrite, review, and/or approve site validation protocols and summary reportsPerform internal and supplier audits as requiredPrepare reports and data related to departmental objectives or requirements (such as APR)

Oversee hourly quality personnel (scheduling, performance reviews, disciplinary action, hiring & firing)Skills:

Self-starterPositive attitudeAble to work in fast-paced environmentAbility to generate and comprehend technical/analytical reportsIn-depth knowledge of the regulatory environment for manufacture of OTC/FS.

Capable to manage tasks in matrix and ability to interact successfully with multi-functions globally and regionallyStrong analytical, problem solving, and decision-making skillsExcellent verbal and written communication skillsSuccess working with multifunctional, regional and global teamsExcellent communication/negotiation skills requiredExtensive working knowledge of applicable quality and regulatory standards and regulationsExperience in risk management, validation, analytics and microbiology, within a GMP environmentRequirements:Must be certified in food safety (SQF, HACCP, or equivalent)

Domestic travel (<10%)Experience managing othersAble to sit/stand for periods lasting 2 hours or moreAble to work in unconditioned environments {both hot and cold)Must be able to wear company issued protective equipmentQualifications:
Education: Associate degree, plus 5 years of quality experience, including supervisory experience; or BS degree

Experience:
Minimum of At least 4 years working in a regulated environment Minimum of 2 years of supervisory experience#J-18808-Ljbffr