Principal Quality Specialist

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 a proven regulatory track record.

About the role

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. This role is proficient in all document and protocol approvals applicable to the respective processes executed at the manufacturing facility. Responsibilities include reviewing documents and data, conducting audits and inspections, consulting on quality and compliance issues, maintaining quality databases, performing trend analysis, and delivering quality and compliance training. The position serves as the quality host for client and regulatory agency audits and inspections, develops SOPs or other quality documents as needed, and provides guidance and mentoring for other Quality employees. The role also serves as a back-up to site Quality Management for technical Quality decision-making.

Responsibilities

• Performs quality review and approval of documents, data, protocols, and/or reports, including complex documents.
• 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, including floor audits.
• Supports client audits and inspections, and regulatory inspections.
• Maintains quality databases and performs analysis and trending.
• Assists with implementation and supports quality systems, including operations support, batch review and approval, training, vendor management, and regulatory inspectional readiness.
• Assists with and leads quality improvement initiatives as needed.
• Consults with clients on production and documentation, including complex quality and compliance topics.
• Assists with and develops SOPs or other quality documents and reports.
• Provides quality evaluation and release of support materials, products, equipment, and facilities as required.
• 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.
• Serves as back-up to site Quality Management for technical Quality decision-making.
• Other duties as assigned.

Requirements

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

Skills

• Aseptic parenteral manufacturing experience.
• Grade C gowning qualification.
• GMP and Annex 1 experience.
• Visual acuity for inspections.
• Strong knowledge of regulations and SOPs applicable to the area of responsibility; stays abreast of new regulations and regulatory guidance.
• Good written and oral communication skills.
• Good math skills.
• Proficiency in Microsoft Office products.
• Ability to be trained and to mentor others.
• Ability to act independently and as a technical consultant.
• Strong interpersonal skills to interact well with clients, regulatory agents, and employees at all levels.
• Negotiation skills.
• Uses professional concepts and company policies/SOPs to solve a variety of problems.
• Receives minimal instruction on day-to-day work; general instructions on new assignments.

Schedule

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

Travel Expectations

Up to 5% travel required.

Physical Demands and Work Environment

The physical demands and work environment described 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 frequently required to stand, walk, and sit, and may occasionally be 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 include close vision, distance vision, and peripheral vision.
• 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 need to access lab or manufacturing areas for inspections or work discussions, where noise levels may be louder.
• The employee is required to wear appropriate personal protective equipment, which may include safety eyewear, respirators/breathing apparatus, lab coats, and gloves.