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Sr. Manager, QC Improver

Company: Emergent BioSolutions
Location: Lansing
Posted on: January 15, 2020

Job Description:

Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life.

Responsible for providing direction of Quality Control laboratory activities related to major and critical investigations with its corresponding corrective and prevention action. Responsible for method improvements and method optimization that provide efficiency and flexibility to the Quality Control laboratory. Through a culture of continuous innovation, responsible for communication to the QC Value Stream and the site by becoming a liaison with Hoshin supported activities.

Responsibilites

* Work closely with the team of professional to identify root cause and corrective actions and preventive actions for complex investigation (major and critical) that prevent recurrence. Deliver the closure of the investigation on time.
* Provide technical support to the Vaccine and Auto-injector Business units at Lansing and contract testing laboratories.
* Responsible for method improvements and method optimization that provide efficiency and flexibility to the Quality Control laboratory by embracing continuous innovation
* Manage the QC Improvers team. Develop and coach direct reports to achieve goals based on corporate objectives and results by optimizing resources and building team effectiveness
* Ensure compliance with the cGMP/USDA/Animal Welfare regulations and current procedures
* Responsible for coordinating activities that guarantee the completion of strategy project in the agreed time with the customer
* Coaches employees through problems of diverse scope in which analysis of situations or data requires evaluation of intangible factors. Directs subordinates to complete assignments through the interpretation of established USP, EP, FDA, MHRA, GXP guidelines and policy requirements.
* Perform program assessments and drive continuous improvements for identified gaps and to streamline processes
* Responsible for data review and approval for laboratory documentation
* Represent the Quality Control Department at various company meetings including Hoshin committee
* Collaborate and communicate with other functional areas to promote understanding and achieve strategic objectives
* Manages the development of these employees, while recognizing contributions, mitigating conflict and communication problems, planning and facilitating team meetings, using a skills-based approach to select personnel for DR resolution, and motivating members of the functional areas
* Promptly notify line management & Quality leadership of potential issues or problems
* Conduct personnel interviews, performance reviews, develop and administer enhancement plans, follow-up on personnel issues, and conduct terminations when necessary
* Share best practices across functional units
* Oversee the qualification and requalification of personnel
* Conduct routine walk through ("in life" audits) to maintain an audit readiness
* Provide assistance to the Quality Control Value Stream, Quality Control Laboratory Management and QC Support units when needed
* Demonstrates accountability and promotes company core values through leading the group in overcoming challenges to key deliverables.

The above statements are intended to describe the general nature of work performed by those in this job. It is not an exhaustive list of all duties, and other duties may be assigned.

Education, Experience & Skills

* Bachelor's Degree in Chemistry sciences, Microbiology or closely related field. A Masters degree is preferred.
* Minimum of 8 years of laboratory work experience with increasing responsibilities
* Must have sound knowledge of the functions and expectations of a laboratory animal operations or research facility
* Must have proficiency in cGMP/GLP practices in a FDA/Health Canada/ MHRA regulated environment
* Must have SOP, investigation, and project protocol writing skills
* Must have good verbal and written communication skills
* Previous experience with Laboratory Information Management Systems. Proficiency in MS Office products or comparable word-processing and spreadsheet skills are required
* Must have an understanding of cGMPs, GLP, CFR, USDA, USP,EP and Animal Welfare
* Prior experience with regulatory (FDA/USDA/MHRA/Health Canada etc) inspections
* This position will require animal handling/testing
Physical/Mental Requirements
Type/keyboard, visual acuity, good eye/hand coordination, stand, walk, sit, twist/turn, climb, reach outward, reach above shoulder, hand dexterity, bend, squat/kneel, sense of feel, sense of hearing, sense of smell, lift/carry 50 lbs, and pull 100s. Use phone, fax, copier, and computer. Use hand tools and operate fork lift. Organize/coordinate, analyze/interpret, calibrate precise measurements, problem solve, make decisions, supervise, plan, communicate, prepare written communications, and prepare transaction documents. Drive automatic/standard vehicle. Work outdoors, around noise above conversation level, in hot/cold temperatures, in high humidity, where ventilation is needed, in multiple locations, with restricted access to laboratory, in contact with Select Agents, and with exposure to animals, animal areas, or equipment used in animal areas.

Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by federal, state or local law.

Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy .

Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency.

Keywords: Emergent BioSolutions, Lansing , Sr. Manager, QC Improver, Executive , Lansing, Michigan

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