Sr. Quality Specialist

Free Healthcare Option | Bonus Program | 401(k) with Match | College Loan Forgiveness
Core Values: Trustworthy, Relentless, Accountable, Collaborative, Customer-Focused, and Skilled

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.

Are you interested in joining our team?

Job Summary:

The Sr. Quality Specialist (Laboratory Quality Operations) is accountable for driving results in a fast-paced environment by effectively performing activities of significant variety and complexity to ensure quality and compliance with applicable regulatory requirements and Standard Operating Procedures. These activities may include reviewing documents, conducting more complex, process-focused 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 may serve as quality host for client audits and inspections and provide support during regulatory inspections. The position assists with the development of SOPs or other quality documents as needed and may provide guidance and mentoring for other employees in areas of expertise. This position will also support other Quality aspects of the laboratory including equipment qualification, deviation/investigation review, CAPA planning, equipment qualification and Test Procedures. The Senior Quality Specialist must have good organizational skills, be detailed oriented, and be able to manage multiple tasks with competing priorities.

On-Site Expectations:

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

Responsibilities:

• Performs quality review and approval of documents including CAPA, Action Trackers, Effectiveness Checks, Laboratory Investigations, Deviations, Change Controls, Equipment Validation documents, Test Procedures, client and internal reports, Computer System Validation documents, Standard Operating Procedures, Work Instructions and Forms/Logbooks.
• Performs complex quality floor audits and/or floor inspections.
• Maintains quality databases.
• Assists with quality improvement initiatives as needed.
• Assists with development of SOPs or other quality documents as needed.
• Ensures timely completion and compliance with cGMP and all other relevant company training requirements and Standard Operating Procedures.
• Provide support to management in other data-related tasks such as guardianship of matrixes and KPI.
• Supports client and regulatory audits.
• Other duties as assigned.

Qualifications:

• Bachelor's degree in Chemistry, Biology, or related scientific field.
• Pharmaceutical laboratory experience including at least six years in GMP QA/QC/Compliance.

Knowledge, Skills, and Abilities:

• Highly organized and detail oriented.
• Ability to multitask and adapt in a fast-paced environment.
• Experience with Nonconformance/Deviation and CAPA programs.
• Experience in laboratory equipment qualification and computer system validation desired.
• Ability to work independently, along with the ability to work well within a team, and willing to work overtime or off schedule as needed to meet demands of Center.
• Ability to communicate effectively, both orally and in writing.
• Knowledge of GMP documentation, procedures, and systems as related.
• Excellent computer skills (Microsoft Word and Excel).

Travel Expectations:

• Up to 5% travel to clients is required.

Physical Demands and Work Environment:

The physical demands 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 stand. The employee is occasionally required to walk; sit 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 frequently exposed to moving mechanical parts and risk of electrical shock, burn hazards and microbial contamination. The employee is occasionally exposed to fumes or airborne particles, toxic or caustic chemicals and vibration. The noise level in the work environment is usually moderate. The employee will be required to wear the appropriate personal protective equipment for specific job duties to be performed. 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.

About Us:

Alcami is a contract development and manufacturing organization headquartered in North Carolina with over 40 years of experience advancing products through every stage of the development lifecycle. At Alcami, we are a team of dynamic, agile individuals committed to developing life-saving drugs around the world. A mindset of collaboration, innovation, responsiveness, 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, professional growth, and the opportunity to be part of our skilled team with over 40 years of experience as champions that are dedicated, trustworthy, and relentless to advancing products through every stage of the development cycle. Alcami offers an extraordinary opportunity, a competitive salary, and an exceptional benefits package including medical, dental, vision, and prescription coverage, life, LTD, STD, 401(k) with match and immediate vesting, and tuition reimbursement / student loan forgiveness.

Diversity and Inclusion:

Alcami is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.