Candidate will be responsible to provide leadership for Analytical/Microbiological Laboratory operations within the Rochester Quality organization, and associated laboratory functions for the Penicillin manufacturing operations. This also includes laboratory lot release, change control review and approval as it pertains to lab operations, manufacturing support, record approvals, test plan changes, project support and investigations.
Provides guidance and coaching to laboratory colleagues and provides direction/approval of activities and decisions. Cultivates and reinforces appropriate group values, norms, and behaviors. Provides oversight to individuals and team on personal development, performance, and quality related issues. Writes and delivers performance reviews and performs second level reviews as required. Provides oversight of department, ensuring proper use of assets, budget, and personnel. Communicates effectively with key customers and partners, both within the site and outside of it.
This position leads a team of individual contributor direct reports with a wide range of quality responsibilities including:
+ QC Combination Product and Raw Material Testing - consists of a team of chemists and microbiologists who are responsible for testing of all drug product batches.
+ Coordinating daily operations and ensuring team members are trained in their job function and current revisions of relevant local area SOPs.
+ Ensure the QC laboratories are operating in a safe and effective manner.
+ Establish procedures for receipt and distribution of manufacturing test samples.
+ Ensure relevant test method assays are performed on samples in support of release testing programs and associated stability studies.
+ Support any validation, technology transfer and qualification of test methods and processes as required
+ Troubleshoot laboratory methods and instrument problems.
+ Establish and monitor trend analysis program.
+ Maintain the capacity plan for the team and update on resource requirements to the site quality lead.
+ Develop SMART Objectives for the full team
+ Develop development plans focusing on the 70:20:10 guidelines
+ Develop CI capability and utilize CI tools to drive improvements within your area
+ Manage the training, motivation and development of an excellent team of Quality professionals within the Lab function.
+ Contribute to Continuous Improvement efforts with new technology assessments and awareness to of relevant industry/regulatory changes relevant to Micro and analytical instrumentation and methods.
+ Thoroughly evaluate lab investigations, deviations, and associated corrective/preventive actions to ensure they are handled appropriately and documented effectively as they relate to the testing of raw materials, in-process samples, and final products.
+ Track and trend analytical data to ensure data integrity of laboratory results and all instrumentation and systems are functioning properly.
+ This role will assist with the Rochester Medical Device and Combination product program as needed - conduct impact assessments to changes and participate in CAPA Review Board (CRB).
+ Manage the site's stability program.
+ Control the departmental cost within the budgets.
+ Interface with Regulatory Agencies in audits, track and report metrics for all internal auditing activities.
+ Take independent actions and decisions and motivate key stakeholders to deliver quality outcomes for business requirements.
+ Other duties as assigned by management.
The incumbent is responsible for the development, mentoring, and performance management of a team of about 6-8 Laboratory professionals.
This position is responsible to maintain the structure to ensure that all quality commitments and timelines are tracked and met. In addition, assist the senior leaders at the site in resource and budget preparations.
**Education:** BS/MS or PhD in Chemistry, Biochemistry, Microbiology, Pharmacy or related science and minimum of 7 years of related experience.
+ Minimum of 7 years of related experience in a cGMP environment, as described above, with a strong working knowledge of a variety of quality systems and processes including Drug, and Combination products. Prior experience in managing lab operations is required. The candidate must have demonstrated proficiency in organizational and project management skills and must be able to balance multiple priorities.
+ The candidate must have experience in at least several of the following: GMP (21 CFR parts 210, 211, 820), ISO 13485, Regulatory (worldwide), laboratory deviation investigation, instrument validation, laboratory testing and investigations.
+ Communication: Excellent written and verbal communication skills with the ability to share vision, direction, and data with colleagues across all levels and in a wide range of different work groups including senior leadership and regulatory agencies.
**Communication:** Excellent written and verbal communication skills with the ability to share vision, direction, and data with colleagues across all levels and in a wide range of different work groups including senior leadership and regulatory agencies.
**Reasoning Ability:** Strong analytical and problem solving abilities.
+ Understand regulatory requirements and audit strategy
+ Review and approve cGMP Documentation to assure compliance with regulatory requirements
+ Assess Deviation impacts and resolution
+ Review and approve cGMP Changes in accordance with regulatory requirements
+ Review and approve training to assure cGMP requirements are met
+ Manage Resources to meet organizational goals
+ Understand site financial systems
+ Understand Safety concerns and maintain safe environment (5S, ergonomics)
+ Ability to perform GAP assessments for new & revised PQS
+ Ensure participation in company-wide knowledge exchanges
+ Review and approve all master documents pertaining to the manufacture, analysis, storage, and stability of cGMP products.
+ Ability to thoroughly evaluate quality investigations, deviations, laboratory investigations, and follow-up actions are documented as they relate to the manufacturing, testing, distribution of raw materials, containers, closures, packing materials, labeling, in-process materials, and final product.
+ Knowledge of all drug products and medical devices to assure compliance with applicable regulatory requirements
+ **This is a penicillin manufacturing facility. Candidates applying must NOT be allergic to penicillin.**
+ Able to sit and stand for extended periods of time
+ Critical thinking and ability to pay attention to detail
+ While performing the duties of this job, the employee is occasionally exposed to work near moving mechanical parts. The noise level in the work environment is usually moderate.
+ While performing the duties of this job, the employee is occasionally required to stand; use hands to finger, handle or feel; reach with hands and arms; climb or balance; walk; sit and talk or hear.
+ The employee must occasionally lift and/or move up to 25 pounds.
+ Specific vision abilities required by this job include ability to adjust focus.
**NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS**
+ May require work beyond typical business hours
+ May require travel 0-5%
**Other Job Details**
+ **Eligible for Employee Referral Bonus**
+ **Eligible for Relocation Package**
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Quality Assurance and Control