Project Specialist
Position Summary The Project Specialist is accountable for driving results in a fast-paced environment by supporting project managers for assigned tasks and ensuring completion of project deliverables for either API, drug product or analytical testing to meet customer standards, satisfaction and timelines.
The position requires superior leadership behaviors of the Alcami core competencies and non-negotiables, as well as expertise in functional competencies including knowledge and use of Alcami electronic systems and processes for project management, ability to engage with multi-disciplinary project teams, meeting standards in a GMP environment, managing multiple and sometimes competing priorities, excellent critical thinking and problem solving, attention to detail, results orientation, and verbal and written communication skills.
This position can be also be located in Durham, NC or St.
Louis, MO.
Essential Functions Works collaboratively with internal teams to facilitate all job functions.
Perform administrative duties to support PMs as needed, including but not limited to pulling data, CoAs, invoice resolution, documentation exchange, etc.
Supports project managers for inter-site and external shipping of customer samples and product, including submission into the shipping schedule.
Responsible for all sample logs (SCU, CSR, CCN) acting as client advocate to facilitate timely sample log in.
Supports timely completion of open actions identified in client meetings and follows-up with the appropriate party to drive resolution.
Internally coordinates testing that occurs across multiple sites and/or supports manufacturing at Alcami.
Supports project managers for customer site/plant visits.
Tracks and prepares metrics for Project Management KPIs used internally and for client business reviews.
Supports the Project Management Office (PMO) for implementation of process and system initiatives.
Acquires expertise in the customer interactive electronic systems and supports troubleshooting as required.
Facilitates project check lists to ensure we have all necessary material and supplies for projects.
Monitors incoming materials or samples ensures proper documentation and communicates to the appropriate project manager to ensure timely resolution.
Supports timely exchange of GMP documentation for review and approval such as test methods, specifications, stability protocols, and batch records.
Reviews forecast and pending items to ensure target revenue dates are aligned with schedule and communicates with the appropriate project manager to ensure timely resolution.
Acts as the initial point of contact for inactive projects until a project manager needs to be assigned.
Ensures timely completion and compliance with cGMP and all other relevant company training requirements.
Completes other assignments and tasks as assigned.
Education and Experience Bachelors degree in business, technical or scientific discipline required.
1 to 4 years of related pharmaceutical or analytical laboratory experience required.
Prior project management and/or CDMO 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 Excellent leadership, written and verbal communications and ability to influence others required.
Excellent critical thinking, problem solving, detail and results orientation required.
Ability to manage multi-disciplinary project teams required; prior demonstration of experience preferred.
Awareness or prior work experience in a GMP environment preferred.
Travel Requirements Up to 5% travel required.
Physical Demands and Work Environment The physical demands and work environment 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 sit.
The employee is occasionally required to stand; walk and stoop, kneel, crouch, or crawl.
The employee must 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, color vision, peripheral vision, depth perception and ability to adjust focus.
The noise level in the work environment is usually quiet with periods of higher noise elevations when present in warehouse or manufacturing areas.
The employee may be required to gain access to lab personnel via general lab or manufacturing areas only for work discussions or follow-up or be required to tour clients through the various facilities.
The employee is required to wear the appropriate personal protective equipment to perform the job duties.
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.
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.
#LI-HYBRID Recommended Skills Api Administration Attention To Detail Communication Conflict Management Critical Thinking Estimated Salary: $20 to $28 per hour based on qualifications.
The position requires superior leadership behaviors of the Alcami core competencies and non-negotiables, as well as expertise in functional competencies including knowledge and use of Alcami electronic systems and processes for project management, ability to engage with multi-disciplinary project teams, meeting standards in a GMP environment, managing multiple and sometimes competing priorities, excellent critical thinking and problem solving, attention to detail, results orientation, and verbal and written communication skills.
This position can be also be located in Durham, NC or St.
Louis, MO.
Essential Functions Works collaboratively with internal teams to facilitate all job functions.
Perform administrative duties to support PMs as needed, including but not limited to pulling data, CoAs, invoice resolution, documentation exchange, etc.
Supports project managers for inter-site and external shipping of customer samples and product, including submission into the shipping schedule.
Responsible for all sample logs (SCU, CSR, CCN) acting as client advocate to facilitate timely sample log in.
Supports timely completion of open actions identified in client meetings and follows-up with the appropriate party to drive resolution.
Internally coordinates testing that occurs across multiple sites and/or supports manufacturing at Alcami.
Supports project managers for customer site/plant visits.
Tracks and prepares metrics for Project Management KPIs used internally and for client business reviews.
Supports the Project Management Office (PMO) for implementation of process and system initiatives.
Acquires expertise in the customer interactive electronic systems and supports troubleshooting as required.
Facilitates project check lists to ensure we have all necessary material and supplies for projects.
Monitors incoming materials or samples ensures proper documentation and communicates to the appropriate project manager to ensure timely resolution.
Supports timely exchange of GMP documentation for review and approval such as test methods, specifications, stability protocols, and batch records.
Reviews forecast and pending items to ensure target revenue dates are aligned with schedule and communicates with the appropriate project manager to ensure timely resolution.
Acts as the initial point of contact for inactive projects until a project manager needs to be assigned.
Ensures timely completion and compliance with cGMP and all other relevant company training requirements.
Completes other assignments and tasks as assigned.
Education and Experience Bachelors degree in business, technical or scientific discipline required.
1 to 4 years of related pharmaceutical or analytical laboratory experience required.
Prior project management and/or CDMO 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 Excellent leadership, written and verbal communications and ability to influence others required.
Excellent critical thinking, problem solving, detail and results orientation required.
Ability to manage multi-disciplinary project teams required; prior demonstration of experience preferred.
Awareness or prior work experience in a GMP environment preferred.
Travel Requirements Up to 5% travel required.
Physical Demands and Work Environment The physical demands and work environment 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 sit.
The employee is occasionally required to stand; walk and stoop, kneel, crouch, or crawl.
The employee must 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, color vision, peripheral vision, depth perception and ability to adjust focus.
The noise level in the work environment is usually quiet with periods of higher noise elevations when present in warehouse or manufacturing areas.
The employee may be required to gain access to lab personnel via general lab or manufacturing areas only for work discussions or follow-up or be required to tour clients through the various facilities.
The employee is required to wear the appropriate personal protective equipment to perform the job duties.
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.
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.
#LI-HYBRID Recommended Skills Api Administration Attention To Detail Communication Conflict Management Critical Thinking Estimated Salary: $20 to $28 per hour based on qualifications.
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