What are the responsibilities and job description for the Senior Metrologist position at Alcami Corporation?
Position Summary
The Senior Metrologist is accountable for driving results in a fast-paced environment by performing diagnostics repair of analytical instrumentation including HPLC, gas chromatography and laboratory equipment; performing instrument calibrations in a pharmaceutical laboratory environment, maintaining calibration of metrology standards, and completing and reviewing calibration documents. The ideal candidate will use computerized equipment and software to perform testing functions and produce graphs and will serve as a mentor to junior team members. The position requires superior leadership behaviors of the Alcami core competencies and non-negotiables, as well as expertise in functional competencies included in this position profile.
Essential Functions
- Performs maintenance, testing, troubleshooting, calibration and repair on a variety of circuits, components, analytical equipment and instrumentation for pharmaceutical laboratory and manufacturing equipment.
- Specifies and requests purchase of components.
- Utilizes several database systems.
- Analyzes results and may develop test specifications.
- Maintains all logs and required documentation.
- Prepares technical reports with recommendations for solutions to technical problems.
- Reads, writes and follows Standard Operating Procedures (SOP’s).
- Documents Calibrations, PMs, Out-Of-Tolerances (OOT’s) and Deviations.
- Disassembles and reassembles instruments and equipment, using hand tools, and inspects instruments and equipment for defects.
- Establishes Calibration and PM protocols for new and existing instruments and systems.
- Modifies performance and operation of component parts and circuitry to specifications, using test equipment and precision instruments.
- Act as a liason with outside contractors/vendors for instrument repairs.
- Selects sensing, telemetering, and recording instrumentation.
- May be required to coordinate coverage during off-hours to ensure effective emergency response for supported instrumentation
- Ensures timely completion and compliance with cGMP and all other relevant company training requirements.
- Act as project manager to support new instrument on-boarding or existing equipment changes
Education and Experience
- Minimum of a two-year degree in a technical discipline (A.S. or A.A.S.), or equivalent military education (60-credit hours) and training
- 4 years previous calibration/instrumentation experience preferred
- Previous support experience with analytical laboratory type instrumentation
- Previous experience working in a GMP environment preferred
- ASQ Calibration Technician Certification (CCT) and/or military PMEL training is a plus
- ProCalV5 Calibration Management System software experience highly desirable
Alcami Non-Negotiables
- Consistently demonstrates honesty and integrity through personal example.
- Follows all safety policies and leads by example a safety-first culture.
- Produces high quality work product with a focus on first time right.
- Complies with the company code of conduct and policies and regulatory standards.
Alcami Core Leadership Competencies
- Thinks strategically. Quickly identifies and acts on opportunities. Considers the downstream impact. Seeks to understand the why. Focuses on work that matters.
- Develops organization and others. Takes ownership to develop self and others. Seeks out new opportunities and experiences for continuous learning.
- Acts decisively. Makes and acts on decisions quickly. Makes decisions with the customer and their patients in mind. Meets commitments with a sense of urgency. Seeks ways to be more efficient.
- Drives performance. Holds self and others accountable. Delivers results first time right. Never settles for status quo. Willing to have tough conversations. Asks for feedback and takes action to improve.
- Passion for customers. Listens to understand. Asks the right questions. Gets to the heart of the matter and uses that insight to provide value.
- Works collaboratively. Seeks out the experience of others with the aim for better results. Open minded regardless where ideas originate. Flexible and easy to work with.
Functional Competencies
- Excellent mechanical ability and working electrical knowledge required.
- Excellent computer, organizational, scheduling skills required.
- Excellent knowledge of calibration services.
- Working knowledge of metrological traceability and its criticality to quality calibration program.
- Working knowledge of cGMP in a pharmaceutical or regulated environment required.
- Excellent verbal communications and presentation skills required.
- Ability to train and influence other team members.
- Strong math aptitude and superior problem-solving abilities required.
- Proficiency with Microsoft Office (Word, Excel, PowerPoint) required.
- Commitment to maintaining technical knowledge and skills, perform all work with high integrity and confidence.
- Ability to interpret moderate-to-complex technical and statistical information.
Decision Making and Supervision Required
- Uses professional concepts and company policies and SOPs to solve a variety of problems.
- Receives minimal instruction on day-to-day work, general instructions on new assignments.
Travel Requirements
- Up to 5% Travel required
Physical Demands and Work Environment
The physical demands and work environment characteristics described here are representative of those that must be met or encountered 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 is regularly required to stand; use hands to finger, handle, or feel; reach with hands and arms; talk or hear and smell. The employee is frequently required to walk; climb or balance and stoop, kneel, crouch, or crawl. The employee is occasionally required to sit. The employee must regularly lift and/or move up to 10 pounds, frequently lift and/or move up to 25 pounds, occasionally lift and/or move up to 50 pounds and occasionally lift and/or move over 50 pounds with assistance. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.
While performing the duties of this job, the employee is frequently exposed to moving mechanical parts; fumes or airborne particles and toxic or caustic chemicals. The employee is occasionally exposed to wet and/or humid conditions; high, precarious places; risk of electrical shock and vibration. The noise level in the work environment is usually moderate. The employee will be required to wear the appropriate personal protective equipment for specific job duties to be performed. Such personal protective equipment may include, but not limited to: safety eyewear, hearing protection, various types of respirators/breathing apparatus, lab coats, full protective body coverings, various types of gloves, etc.
Other Duties
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.