Analytical Lead

Leiters • $80K — $95K *
Pharmaceuticals & Biotech
Less than 5 years of experience
Job Overview by Ladders

Qualifications

  • 2+ years of Quality experience required; 1+ years in a leadership capacity preferred.
  • Strong problem solving skills, ideally with Six Sigma and Lean training, Green Belt or Black Belt preferred.
  • Demonstrated written and oral communication skills, including strong presentation skills.
  • Excellent organizational skills with a strong results orientation.
  • Familiarity with 503B regulatory requirements, cGMP standards, and USP guidelines is a plus.
  • Proficient in Microsoft 365 tools including Outlook, Word, and Excel.

Responsibilities

  • Lead daily operations of Quality Analytical activities.
  • Foster a positive work environment via effective communication.
  • Ensure all SOPs are up-to-date and training is current.
  • Analyze efficiencies, downtime, and waste to drive improvement initiatives.
  • Facilitate problem-solving and root cause analysis for department issues.
  • Write investigations and CAPA actions for non-conformances.
  • Collaborate with cross-functional teams on investigations.

Benefits

  • Comprehensive healthcare coverage options that encourage wellness.
  • Flexible Spending & Health Savings Accounts (FSA & HSA) available.
  • Dental and Vision insurance included.
  • Employer Paid Life Insurance and Employee Assistance Program.
  • Short Term & Long-Term Disability Insurance coverage.
  • Up to 4% 401K matching, fully vested on day one.
  • Generous Paid Time Off including vacation, sick leave, and holidays.
  • $5,250 annual tuition reimbursement after 6 months.
  • $1,000 referral bonus program with no limit.
  • Eligibility for annual bonus program.
Full Job Description
The Analytical Lead reports directly to the Quality Manager. The role is responsible for the day-to-day support and leadership of quality control activities.

Essential Functions:
  • Daily leadership of employees who are responsible for Analytical activities.
  • Provide a positive work environment through effective communication.
  • Ensure all SOPs are current, and training on SOPs and processes remains current.
  • Analyze Analytical efficiencies, downtime, and waste. Lead improvement initiatives. Participate in finding a "better way".
  • Lead problem solving activities and root cause analysis for department variances or deviations.
  • Write investigations and CAPA actions for non-conformances in the department.
  • Work with cross-functional teams to conduct investigations.
  • Other duties as assigned.

Supervisory Responsibilities:
  • N/A

Experience and Necessary Skills:
  • 2+ years of Quality experience required; 1+ years in a leadership capacity preferred.
  • Strong problem solving such as Six Sigma and Lean training, Green Belt or Black Belt preferred
  • Demonstrated written and oral communications skills including strong presentation skills.
  • Excellent organizational skills.
  • Strong results orientation.
  • Good understanding of 503B regulatory requirements, cGMP standards, and USP guidelines isa plus!
  • Proficient written, verbal and oral English communication skills are required.
  • Proficiency with Microsoft 365 tools including Outlook, Microsoft, and Excel.


Physical Requirements:
  • Ability to stand or sit for extended periods of time.
  • Ability to lift, push and pull up to 50 pounds periodically.
  • Ability to maintain a gowning qualification, if applicable.

Benefits:
  • Smart healthcare coverage options that rewards wellness (and puts money back in your pocket!)
  • Flexible Spending & Health Savings Accounts (FSA & HSA) available
  • Dental & Vision insurance
  • 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

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

*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.

#leitersjobs

About Leiters

Leiters is a pharmaceutical company that specializes in developing and manufacturing sterile injectable products. The company was founded in 1926 and is headquartered in McKinney, Texas. Leiters has a state-of-the-art manufacturing facility that is FDA-approved and operates under current Good Manufacturing Practices (cGMP). The company's products are used in hospitals, surgery centers, and clinics across the United States. Leiters is committed to providing high-quality products and exceptional customer service to its clients.
Learn more about Leiters
Size
400 employees
Industry
Net Income
$10 million
5 Year Trend
+10%
Revenue
$100 million

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