What are the responsibilities and job description for the Associate Director, Calibration Services position at Alcami Corporation?
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Job Summary:
While performing the duties of this Job, the employee is frequently exposed to moving mechanical parts and risk of electrical shock. The employee is occasionally exposed to fumes or airborne particles, toxic or caustic chemicals 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, various types of respirators/breathing apparatus, lab coats, full protective body coverings, various types of gloves, etc.
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?
The Associate Director, Calibration Services is responsible for the overall direction of the metrology department. Provides leadership and mentoring to lab personnel. Conducts the lab activities in compliance with the quality management system. Provides technical guidance. Actively supports and maintains ISO 9001 certification and ISO 17025 accreditation. Improves lab competence, efficiency, and effectiveness. Defines and directs the short and long-term goals of the department. Direct responsibility for departmental P&L. This position provides managerial guidance for the administrative support for Alcami Pharma Services. The Associate Director assists with lab issues as they arise, handles routine questions and problems, and interfaces with customers and other departments as necessary. The Associate Director provides training and mentoring to all staff that report into the role.
On-Site Expectations:
- 100% on-site position.
- 1st Shift: Monday - Friday, 8:00am - 5:00pm.
- Represents the department in meetings, collaborates, and cooperates to achieve cross-functional improvements and business goals.
- Creates departmental systems and fosters a culture of continuous improvement focused on value to the customer.
- Manages the day-to-day operations for assigned area.
- Ensures all staff members are fully trained.
- Participates in and supports client visits, audits, and inquiries to ensure complete fulfillment of requests and interests.
- Recruits, trains, develops, and retains staff for the effective process of departmental operations.
- Provides technical guidance for troubleshooting and investigating simple to complex issues in the area of expertise.
- Applies statistical analysis for interpretation of project data.
- Ensures all cGxP data generated for projects are managed and evaluated as described in relevant internal procedures and regulatory requirements.
- Effectively resolves quality issues and concerns in a timely manner.
- Actively contributes to the preparation and coordination of internal audits and regulatory inspections.
- Creates strong and effective relationships with clients.
- Maintains a high level of professional and technical expertise through familiarity with scientific literature, conference attendance, and participation in training courses.
- Prioritize goals to meet company objectives.
- Approve metrology methods for software, hardware, & instrumentation.
- Establish and schedule testing to support lab accreditation, evaluate test results and personnel.
- Determine and document appropriate methods for estimating uncertainty.
- Evaluate and resolve quality issues relating to metrology.
- Identify and resolve nonconformance in the metrology department.
- Report on metrology activities at Management Review Meetings.
- Provide training and mentoring to staff on general metrology principles and specific metrology procedures, sharing best practices, and industry knowledge.
- Write, revise, review, and approve metrology procedures.
- Evaluate staff and equipment utilization to determine future needs.
- Determine appropriate laboratory housekeeping standards and foster compliance.
- Support sales initiatives as necessary.
- Support staff at both customer and remote Alcami locations.
- Assume responsibility for annual budgeting and costs within the department and review the monthly department income statement with Finance and Senior Management.
- Create a culture which empowers the staff, focuses on the Alcami values, recognizes those who wish to grow/advance and provide them a path to do so.
- Other duties as assigned.
- Bachelor of Science in Metrology, Manufacturing Technology, Engineering or a related technical degree, or 10 years calibration experience with a higher educational degree.
- At least 4 years of management experience.
- Strong technical skills for area managing.
- Basis business acumen.
- Strong understanding of company SOPs and regulatory guidance documents.
- Strong knowledge of safety procedures and quality compliance for assigned area.
- Strong knowledge of cGMP requirements.
- Experience with client audits.
- Strong understanding of basic lab techniques.
- Strong knowledge of FDA, EU, and ICH requirements and implementation for GLP and GMP in the pharmaceutical industry.
- If applicable, experience with compliance for API and drug product and/or drug substance.
- Experience with regulatory agency inspections of GXP facilities.
- Experience working in a CDMO.
- Expert knowledge of metrology disciplines including temperature, electronic, and mechanical.
- Familiarity with major manufacturers’ calibration and metrology instrumentation.
- Excellent written and verbal communication skills.
- Excellent organizational, reporting, and presentation skills.
- Proficiency in GMP/GLP and ISO 17025.
- Ability to initiate team efforts to accomplish goals.
- Results oriented with the ability to balance other business considerations.
- Superior attention to detail and ability to multi-task required.
- Demonstrated ability to work in cross-functional teams.
- Strong level of initiative and flexibility.
- Analytical and detail-oriented with attention to detail and accuracy.
- Excellent verbal communications and presentation skills required.
- Proficiency with Microsoft Office (Word, Excel, PowerPoint) required.
- Positive attitude and team player.
- Demonstrated excellent administrative and leadership abilities.
- Less than 10% travel expected.
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 is regularly required to use hands to finger, handle, or feel; reach with hands and arms; talk or hear and smell. The employee is frequently required to stand; sit and stoop, kneel, crouch, or crawl. The employee is occasionally required to walk. The employee must 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, 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 and risk of electrical shock. The employee is occasionally exposed to fumes or airborne particles, toxic or caustic chemicals 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, various types of respirators/breathing apparatus, lab coats, full protective body coverings, various types of gloves, etc.
