QA Specialist I

Leiters Health; Colorado; On-site; USD 57,000 - 65,000; Full time

Job summary

Leiters Health is seeking a QA Specialist I to ensure product quality and compliance in a collaborative environment. The role involves evaluating batch records, supporting audits, and maintaining quality assurance standards. Join a pioneering pharmaceutical company dedicated to patient safety and innovative solutions.

Benefits

100% employer paid medical plan

Dental & Vision insurance options

Employer Paid Life Insurance

Short Term & Long-Term Disability Insurance

401K Matching

Generous Paid Time Off

$5,250 Annual Tuition Reimbursement

$1,000 Referral Bonus Program

Eligible for annual bonus program

Qualifications

• Knowledge and experience with cGMPs in a commercial compounding facility.
• Ability to identify potential adverse issues.
• Detail-oriented with excellent documentation skills.

Responsibilities

• Evaluate completed batch records to ensure procedures were followed.
• Release batches through ERP system.
• Support internal and external audits.

Skills

Attention to Detail

Excellent Communication

Organization

Education

BS or BA degree in a scientific discipline

Tools

Microsoft Word

Microsoft Excel

Job description

Join to apply for the QA Specialist I role at Leiters Health

Join to apply for the QA Specialist I role at Leiters Health

This range is provided by Leiters Health. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$57,000.00/yr - $65,000.00/yr

Quality Assurance Specialist I

This description is intended to be illustrative of the major duties performed by the employee recruited to this position. Performs other duties as assigned.

This position will report to the Quality Manager. The Quality Specialist evaluates, tracks, trends, and monitors the Quality Assurance activities in an outsourcing facility. The position is responsible for the assurance that the drug product has the safety, identity, strength, quality, and purity represented. The candidate should have an excellent understanding of cGMP requirements. The position requires an individual who works independently and in a team environment, experienced in cGMP requirements, quality assurance, attention to detail, and excellent communication with other functional areas and sites.

Why Join Leiters Health?

Are you passionate about making a real impact in the pharmaceutical industry? Do you thrive in a collaborative, innovative environment where your skills and ideas are valued? Look no further – Leiters Health is seeking talented individuals like you to join our dynamic team!

At Leiters Health, we're not just another pharmaceutical company – we're pioneers in the field, dedicated to delivering high-quality compounded sterile products and outsourced solutions to healthcare providers nationwide. Our commitment to excellence and patient safety is at the core of everything we do.

• Innovative Culture: Be part of a forward-thinking company that encourages creativity, welcomes fresh ideas, and fosters an environment of continuous improvement.
• Meaningful Work: Contribute to a purpose-driven organization dedicated to providing critical medications and healthcare solutions that positively impact patients' lives.
• Professional Development: Access ongoing training, mentorship, and growth opportunities to expand your skills and advance your career within a rapidly growing industry.
• Cutting-Edge Technology: Work with state-of-the-art facilities and advanced technologies, staying ahead of the curve in pharmaceutical manufacturing.
• Collaborative Environment: Join a team of passionate individuals who are dedicated to teamwork, support, and mutual success, fostering a culture of inclusivity and collaboration.
  
  

Who We're Looking For:

We're seeking enthusiastic individuals who are driven, adaptable, and passionate about contributing to a mission-driven organization. Whether you're an experienced professional or just starting your career, Leiters Health provides an environment where your skills and talents will be recognized and appreciated. Sound like you? Apply today!

Essential Functions:

• Evaluate completed batch records and other relevant information to ensure procedures were followed, product tests performed appropriately and acceptance criteria met.
• Release batches through ERP system.
• Assist with monitoring the FMS system and generating FMS weekly report.
• Draft, review or approve sampling instructions, quality assurance procedures, and standard operating procedures.
• Ensure that the required initial and continuing training of personnel is carried out and adapted according to need.
• Review and approve investigations of reprocessing/rework of products, analytical failures, and returns/salvages.
• Classify, file, audit, receive, distribute, track and maintain system of classified and unclassified company documents according to established procedures and standards for security and document organization.
• Supporting or performing internal audits.
• Supporting external regulatory or customer audits.
• Supporting or performing supplier audits.
• Gather information from multiple departments for trending and presentation to management.
• Identify trends in the industry and recommend improvements.
• Work with a team to ensure that the systems involved in an outsourcing facility are in a state of control.
• Other duties as assigned to ensure appropriate quality practices.
  
  

Experience & Necessary Skills:

• Knowledge and experience with the cGMPs , preferably in a commercial compounding outsource facility .
• Able to identify potential adverse issues .
• Excellent organization and documentation skills .
• Detail oriented .
• Computer skills, including Microsoft Word and Excel .
• BS or BA degree (in a scientific discipline desired) .
  
  

Benefits:

• 100% employer paid medical plan.
• Dental & Vision insurance options including FSA & H SA
• Employer Paid Life Insurance & Employee Assistance Program
• Short Term & Long-Term Disability Insurance
• Up to 4% 401K Matching (100% vested on day one!)
• Generous Paid Time Off Options – vacation, sick , paid leave and holidays!
• $5,250 Annual Tuition Reimbursement after 6 months
• $1,000 Referral Bonus Program with no limit
• Eligible for annual bonus program
  
  

Shift: Monday-Friday 1st

Timeline:We will be accepting applications on an ongoing basis until position is filled.

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law.

• Please note that we do not work with third-party recruiters or agencies for this position. If you are a qualified candidate and wish to apply for this job, please do so directly through our official application process. We appreciate your understanding and cooperation in this matter.

Seniority level

• Seniority level

  Entry level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Quality Assurance

• Industries

  Pharmaceutical Manufacturing, Chemical Manufacturing, and Manufacturing

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