Quality Review Specialist at Alcami Corporation in Charleston, South Carolina

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 Quality Review Specialist is accountable for driving results in a fast-paced environment by reviewing content and quality of final client reports from laboratory documentation. The incumbent will ensure that laboratory data is reported in accordance with company SOPs or client requirements. Reviews investigation and deviation notes for inclusion on final reports and analyzes stability data for trending patterns. This 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

• Reviews and approves content and quality of final client reports from laboratory documentation.


• Ensures laboratory data is reported in accordance with company SOPs or client requirements.


• Works closely with GMP and management to expedite/correct data.


• Ensures approved laboratory investigation and deviation notes are referenced for inclusion on final reports.


• Reviews stability data for trending patterns.


• Responsible for accurate and timely data entry.


• Assists with quality improvement initiatives as needed.


• Serves as an effective member of the Quality team and may serve as a mentor to other Quality employees in the area of expertise.


• Monitors late reports to expedite project closure.


• Reviews and updates requested report revisions.


• Reviews ERP documents to monitor priorities and due dates.


• Ensures timely completion and compliance with cGMP and all other relevant company training requirements.

Education and Experience

• Bachelor's degree in Chemistry, Biology or related field with 4+ years related experience, or equivalent educational and work experience.


• Associates degree in scientific field with 5+ years related experience, or equivalent educational and work experience.

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

• Knowledge of GMP/Regulatory procedures.


• Familiarity with lab notebooks.


• Knowledge of Company SOPs.


• Computer proficient, including Microsoft Office software.


• Strong problem solving skills.


• Good oral and written communication skills.


• Excellent attention to detail and data entry skills.

Decision Making and Supervision Required

• Applies job skills, company policies and SOPs to complete a variety of tasks.

• Receives minimal instruction on day-to-day work, general instructions on new assignments.

Travel Requirements

• Up to 5% travel.

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 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. While performing the duties of this job, the employee is occasionally exposed to moving mechanical parts and vibration. The noise level in the work environment is usually very quiet.

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.

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.

What We Offer You:

* Competitive salary with career advancement opportunities

* 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, sexual orientation, 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.

As part of our effort to provide and maintain a safe and healthful workplace, Alcami Corporation requires new hires to be fully vaccinated against COVID-19. Individuals are considered fully vaccinated 2 weeks after their second dose of the Pfizer or Moderna vaccine, or 2 weeks after a single-dose of the Johnson & Johnson vaccine. Individuals seeking an exemption from this requirement for medical or religious reasons should contact HR to complete a request for accommodation form.

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