Principal Quality Specialist

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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.

 

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Job Summary:

The Principal Quality Specialist (Manufacturing) is accountable for driving results in a fast-paced environment by effectively performing activities of substantial variety and complexity to ensure quality and compliance with applicable regulatory requirements and is proficient in all document and protocol approvals applicable to the respective processes executed at the respective manufacturing facility.

These activities include reviewing documents and data, conducting audits and inspections, consulting on quality and compliance issues, maintaining quality databases and performing trend analysis where needed, and performing quality and compliance training as needed. The position serves as quality host for client and regulatory agency audits and inspections. The specialist develops SOPs or other quality documents as needed.

A Principal Quality Specialist provides guidance and mentoring for other Quality employees. Serves as a back-up to site Quality Management for technical Quality decision making. The position requires superior leadership behaviors as well as expertise in functional competencies.

On-Site Expectations:

• 100% on-site position.
• 1st Shift: Monday - Friday, 8:00am - 5:00pm.

Responsibilities:

• Performs quality review and approval of documents, data, protocols, and/or reports. 
• Performs GMP document creation and issuance (batch records, logbooks, forms, etc.). 
• Performs visual inspection of parenteral product (requires qualification). 
• Performs internal quality audits and/or inspections. 
• Supports client audits and inspections, and regulatory inspections. 
• Maintains quality databases and may perform analysis and trending.
• Assists with implementation and supports quality systems, including but not limited to, operations support, batch review and approval, training, vendor management, and overall regulatory inspectional readiness. 
• Assists with quality improvement initiatives as needed. 
• Consults with clients on production and documentation.  
• Assists with development of SOPs or other quality documents.  
• Maintains accurate files and records. 
• Serves as an effective member of the Quality Assurance team and may serve as a mentor to others in area of expertise.   
• Complies with company polices and SOPs. 
• Ensures timely completion and compliance with cGMP and all other relevant company training requirements. 
• Serves as back-up to site Quality Management for technical Quality decision making.
• Performs quality review and approval of complex documents, all types of data, protocols, and/or reports.
• Performs quality floor audits and/or floor inspections.
• Supports for client and regulatory agency audits and inspections.
• Provides quality evaluation and release of support materials, products, equipment and facilities as required.
• Maintains quality databases and may perform analysis and trending.
• Assists with quality improvement initiatives as needed.
• Develops quality SOPs or other quality documents and/or reports as needed. 
• Provides consultation on complex quality and compliance topics in areas of expertise.
• Develops and provides training in quality and compliance topics in areas of expertise.
• Serves as client quality liaison for client audits.
• Effectively performs a variety of complex duties, on schedule, with accuracy and competency.
• Maintains accurate files and records.
• Ensures timely completion and compliance with cGMP and all other relevant company training requirements.
• Other duties as assigned.

Qualifications:

• Bachelor’s degree in Chemistry, Biology, or related field with 13+ years of GMP related experience, or Master’s degree in related field.
• Minimum five years of related relevant GMP experience required.

Knowledge, Skills, and Abilities:

• Aseptic parenteral manufacturing. 
• Grade C gowning.
• GMP and Annex 1 experience.
• Visual acuity.
• Strong knowledge of regulations and SOPs applicable to area of responsibility and keeps abreast of new regulations and regulatory guidance in areas of expertise.
• Good written and oral communication skills.
• Good math skills.
• Good computer skills and knowledge of Microsoft Office products.
• Ability to be trained and to mentor.
• Ability to act independently.
• Ability to interact well with clients and regulatory agents.
• Ability to negotiate.
• Ability to interact well with employees at all levels.
• Ability to act as technical consultant.
• 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 Expectations:

• 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 by an employee to successfully perform the essential functions of this job. Reasonable accommodation 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, or manufacturing areas for inspections or work discussions. The noise level in these additional work areas may be louder. 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.