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Supervisor, Laboratory Support Services

Company: Alcami Corporation
Location: Durham
Posted on: October 17, 2020

Job Description:

Think Different. Do Different. Be Different.

Alcami is a world-class contract development and manufacturing organization (CDMO). We are a team of dynamic individuals committed to developing life-saving drugs around the world. A mindset of innovation, accountability and customer focus inspires us to be the most efficient, safe and reliable choice for our customers and the patients they serve. In return, we offer challenging careers, accelerated professional growth and the opportunity to be part of something different.

Position Summary

The Supervisor of Laboratory Support Services is accountable for driving results in a fast-paced environment by managing the daily activities of Laboratory Support Technicians and Material Management / Sample Control Unit (SCU) Specialists. The Laboratory Support Supervisor must have a strong laboratory background and have a detailed understanding of cGMP laboratory operation, including purchasing/receiving, reference standard/sample management, DEA functions, project log in, and lab support activities. The Supervisor will provide mentoring, training, and general guidance and instruction to the group. The Supervisor will work independently on routine work, requiring minimal input from management. 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

* Receives incoming samples for analysis and logs them into system to initiate chain-of-custody tracking.

* Generates projects/laboratory packages for laboratory testing.

* Collaborates with Analytical Laboratory Managers, Project Management, Sales and Business Development, Quality, all Alcami laboratory locations and SCU personnel to ensure accurate processing, including analytical specifications and methods are in place, for accurate project generation and timely delivery of samples for testing.

* Uses multiple computer software programs to log in, manage and maintain material status and testing requirements.

* Performs documentation accurately and completely.

* Manages reference standard inventory and storage.

* Manages laboratory sample storage, chain-of-custody, and disposition.

* Acts as POA and manages DEA activities including year-end inventory, procurement quota, ARCOS reporting, importing/exporting of controlled substances and List I Chemicals

* Performs tasks in support of the laboratory operations and/or schedules these tasks to be completed by a member of their team.

* Monitors temperature and humidity of laboratories and chambers, including maintenance and review of chart recorders in labs.

* Orders and stocks laboratory supplies.

* Completes daily balance checks and monthly spindle checks for dissolution baths daily.

* Inspects chemicals and reagents, and removal of expired materials.

* Ensures training of the group is complete and effectively leads and mentors employees.

* Evaluates and optimizes the quality and efficiency of the processes in the Materials Management & Sample Control Unit areas.

* Drives laboratory and quality improvements.

* Ensures adherence to personnel SOPs and other regulatory requirements.

* Monitors the quality and efficiency of the group.

* Resolves questions through collaboration with laboratory management.

* Maintains consistent, accurate, and up-to-date notes and files.

* Performs duties, on schedule, with accuracy and competency.

* Generates and revises SOPs, as needed.

* Interacts with clients or with the FDA during audits, or to address any potential audit requests or observations.

* Leads and/or assists with controlled drug audits, inspections and inquiries.

* Participates in company sponsored training, as needed.

* Communicates with clients and internal groups effectively.

* 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.

Education and Experience

* Bachelor s degree in a Science filed with 5+ years of related experience in area to be supervised;

* Previous supervisory experience preferred.

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

* Demonstrated knowledge and hands on experience in the area of responsibility.

* Knowledge of cGMP procedures.

* Knowledge of cGMP documentation requirements.

* Basic problem solving abilities.

* Consistent attention to details.

* Proficient with computer.

* Strong oral and written communication.

* Works well in team setting.

Supervisory Responsibilities

* Directly leads team of approximately 2- 9 direct reports.

* Participates in the hiring process of other employees.

* Makes hiring decisions of other employees.

* Schedules and reviews the work of other employees.

* Ensures accuracy and relevance of assigned training curriculum.

* Drives timely completion of training for employees to meet regulatory requirements.

* Coaches, mentors and develops other employees.

* Prepares and delivers performance evaluations of other employees.

* Makes recommendation of disciplinary actions of other employees.

Travel Requirements

* Up to 5% travel required.

What We Offer You:

* Competitive salary with career advancement opportunities

* Profit sharing bonus plan

* Medical, dental and vision coverage from day one

* 401(k) with company match

* Company paid vacation, holiday and sick-leave

* Voluntary benefits including short & long term disability, life, accident, critical illness insurances

Diversity and Inclusion:

Alcami values diversity and we are committed to creating an inclusive environment for all employees. All employment decisions are based on business needs, job requirements and individual qualifications, without regard to race, color, religion, sex, pregnancy, age, national origin, physical or mental disability, past or present military service, marital status, gender identification or expression, medical condition (including genetic characteristics) or any other protected characteristic as established by law.
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Keywords: Alcami Corporation, Durham , Supervisor, Laboratory Support Services, Healthcare , Durham, North Carolina

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