Sr. Supervisor, Metrology - GMP at Alcami Corporation

Wilmington, North Carolina, United States -

Full Time

Start Date

Immediate

Expiry Date

27 Dec, 25

Salary

0.0

Posted On

28 Sep, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Assurance, cGMP, Pharmaceutical GMP, Pro Cal, Communication, Mechanical Skills, Excel, Word, Team Player, Training, Mentoring, Problem Solving, Listening Skills, Self-Motivation, Goal Oriented, Documentation

Industry

Pharmaceutical Manufacturing

Description

At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from discovery to commercialization, through trusted partnership with our clients, recognized industry expertise and proven regulatory track record. Are you interested in joining our team? Job Summary The Sr. Supervisor, 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. On-Site Expectations 100% on-site position. 1st Shift: Monday - Friday, 8:00am - 5:00pm. Responsibilities Leads the metrology 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. Other duties as assigned. Qualifications Requires a related Bachelor’s degree with 5+years of relevant experience within the Pharmaceutical Industry. Must have at least 3+ years of experience in supervisory roles. Knowledge, Skills, and Abilities 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 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. Travel Expectations Up to 10% travel expected. Physical Demands and Work Environment The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee may be required to use hands to finger, handle, or feel and to reach with hands and arms. The employee is required to talk and hear. The employee is frequently required to stand, walk and sit. The employee may be occasionally required to climb or balance. The employee may be required to regularly lift and/or move up to 10 pounds, frequently lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, and peripheral vision. While performing the duties of this job, the employee may be occasionally exposed to moving mechanical parts, high precarious places and vibration. The noise level in the work environment is usually quiet. The employee may be required to gain access to lab, manufacturing or clinical areas for inspections or work discussions. The employee is required to wear the appropriate personal protective equipment to perform the job duties. Such personal protective equipment may include but is not limited to safety eyewear, various types of respirators/breathing apparatus, lab coats, gloves, etc.

Responsibilities

The Sr. Supervisor, Metrology leads the metrology department to optimize the qualification of equipment and systems while maintaining all documentation related to qualification and metrology. This role also involves developing procedures, leading investigations, and ensuring compliance with cGMP requirements.