Qc Data Review Specialist - Bioassay

Position Summary

The Quality Control Data Review Specialist is an effective member of the Laboratory Operations team. Position is accountable for driving results in a fast-paced environment by effectively performing various activities at range of complexity to ensure quality and compliance with applicable regulatory requirements. These activities may include reviewing documents and data, conducting basic floor audits and process inspections, consulting on quality and compliance issues, maintaining quality databases and performing trend analysis where needed, and performing quality and compliance-oriented training as necessary. The QC Data Review Specialist assists with the development of SOPs or other quality documents as needed. 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. Business needs and deadlines will require employee to perform work duties outside of standard work hours on occasion.

Essential Functions

• Serves as an effective member of the Laboratory Operations team and may serve as a mentor to other employees in the area of expertise.
• Assists with continued improvement initiatives as needed.
• Performs detailed review and approval of all types of data and documents (e.g. protocols, reports and test procedures).
• Performs floor inspections with focus on audit trail review and testing process/technique scrutiny as required.
• Ensures timely completion and compliance with cGMP and all other relevant company training requirements.
• Assist in maintaining process KPIs and quality matrix as required.
• Assists with development/writing of SOPs, Work Instructions and other documents and/or reports as needed.
• Provides support to release of materials (e.g. media, reagents) as required.
• Drives alignment of the process with quality and compliance procedures.
• Complies with company polices and SOPs.

Education and Experience

• Bachelor’s degree in Chemistry, Biology, or related field with 2+ years GMP related experience; OR Master’s degree in related field with 1+ years related experience; OR equivalent education and work experience.
• Method validation experience preferred.
• Bioassay experience (ELISA, cell-based relative potency assays, PCR, Flow cytometry for method establishment and routine testing) required.

Alcami Non-Negotiables

• Complies with the company code of conduct and policies and regulatory standards.
• Follows all safety policies and leads by example a safety-first culture.
• Produces high quality work product with a focus on first time right.
• Consistently demonstrates honesty and integrity through personal example.

Alcami Core Leadership Competencies

• 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.
• 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.
• Passion for customers. Listens to understand. Asks the right questions. Gets to the heart of the matter and uses that insight to provide value.
• 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.
• Develops organization and others. Takes ownership to develop self and others. Seeks out new opportunities and experiences for continuous learning.
• Thinks strategically. Quickly identifies and acts on opportunities. Considers the downstream impact. Seeks to understand the why. Focuses on work that matters.

Functional Competencies

• Excellent written and oral communication skills.
• Ability to act independently.
• Ability to host audits.
• Strong knowledge of regulations and SOPs applicable to area of responsibility and keeps abreast of new regulations and regulatory guidance in areas of expertise.
• Proficiency with Microsoft Office products.
• Good math skills.
• Ability to interact well with employees at all levels.
• Ability to be trained and to mentor others.

Decision Making and Supervision Required

• Receives minimal instruction on day-to-day work, general instructions on new assignments.
• Applies job skills and company policies and SOPs to complete a broad range of difficult tasks.

Travel Requirements

• Up to 5% travel required.

Physical Demands and Work Environment

The physical demands 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 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.

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.