Sr. Manager, Metrology

Alcami Corporation•Morrisville, NC

2d•Onsite

About The Position

The Senior Manager of Metrology is accountable for driving results in a fast-paced environment by supervising the daily activities of the Metrology group that performs calibrations, diagnostics, repair, maintenance and equipment qualification of laboratory analytical instrumentation such as HPLC and gas chromatography. The ideal candidate will develop production and resource plans that meet production goals in terms of safety, quality, output, cost and financial savings for the Company. The Senior Manager of Metrology will complete and review calibration documentation and the work of the Metrology team. The Sr. Manager, Metrology is accountable for driving results in a fast-paced environment by supporting general pharmaceutical metrology activities. Specific responsibilities include reviewing SOP’s, composing/revising SOP’s and metrology master plans; supporting facility, utility, manufacturing equipment, and laboratory instrument metrology efforts; conducting reviews of metrology documentation such as metrology plans, system/functional requirements, protocols and summary reports. The position requires strong leadership behaviors and the ability to train and mentor staff.

Requirements

Requires a related Bachelor’s degree in Life Science, Engineering or Electronics with 8+years of relevant experience within the Pharmaceutical Industry.
Must have at least 4+ years of experience in supervisory roles.
Excellent knowledge of quality assurance reviews of metrology and validations documentation.
cGMP training and excellent understanding of requirements.
Excellent knowledge of pharmaceutical GMP environment.
Excellent understanding of and ability to utilize Pro Cal.
Excellent verbal and written communication skills.
Excellent understanding of circuits, components, analytical equipment and instrumentation for laboratory and manufacturing equipment.
Excellent working knowledge of Microsoft Office applications.
Strong verbal and written communication skills.
Ability to supervise, train and mentor employees.
Familiarity with ISO17025 red and current industry calibrations standards such as ASTM preferred.
Excellent mechanical skills.
Strong understanding of Excel.
Strong understanding of Word.
Strong positive team player.
Ability to train and mentor others.
Ability to listen and respond well to external customers, partners, and colleagues at all levels.
Highly goal and result oriented.
Prioritizes tasks according to business objectives and can pursue several objectives simultaneously.
Can work independently with a high degree of self-motivation.
Knows how to obtain support from different collaborations.
Tackles problems with enthusiasm and curiosity.
Treats colleagues at all levels with respect.
Very effective listening skills with the ability to hear attentively and process information correctly.

Nice To Haves

Familiarity with ISO17025 red and current industry calibrations standards such as ASTM preferred.

Responsibilities

Leads the metrolgoy department to optimize the qualification of equipment and systems.
Exercises judgment within defined procedures and practices to determine appropriate action.
Maintains all documentation pertaining to qualification and metrology.
Develops procedures and/or protocols.
Leads investigations as needed.
Develops team metrics, and ensures monthly goals are met.
Serves as information resource for other metrology personnel, contractors and vendors.
Executes and oversees procedures and/or protocols.
Drafts and approves department SOP’s and training modules.
Reviews, composes/revises SOP’s
Owns the laboratory equipment requalification program and compliance to the program.
Acts as a certified trainer for applicable training
Ensures timely completion and compliance with cGMP and all other relevant company training requirements.
Represent Alcami in audits (both client and regulatory) regarding metrology related questions.
Maintains the monitoring system for stability chambers and laboratory incubators.
Ensures adherence to personnel and equipment SOPs and other regulatory requirements.
Pays specific attention to equipment operating practices and conditions to minimize equipment down time, lower maintenance costs, reduce time to run projects and repeat of work.
Develops and executes strategies to improve productivity.
Develops and executes work plans/schedules, using production milestones and division/site performance standards and metrics.
Monitors the progress against the timeline.
Provides troubleshooting support as needed.
Monitors the quality of the group.
Effectively communicates with clients and internal groups.
Ensures timely completion and compliance with cGMP and all other relevant company training requirements.
Attracts, develops, and retains a high performing team to meet the current and evolving needs of the business through effective selection, training and development, coaching and mentoring and performance management.
Other duties as assigned.