The Quality Assurance & Analytical Manager reports to the Associate Director of Quality and is responsible for the assurance that medications produced by Leiters Health have the safety, identity, strength, purity and quality represented in addition to providing assurance that product labelling is accurate and meets associated cGMP requirements. The candidate must possess a keen understanding of cGMP regulations and have experience managing personnel to these standards.
Essential Function:- Review sampling instructions, specifications, test methods, quality control procedures, and standard operating procedures for intended use.
- Approve and monitor analyses carried out under contract through 3rd party private laboratories.
- Monitor the maintenance of the department(s) processes and equipment.
- Investigate reprocessing/rework of products, complaints, analytical failures, deviations, and OOS.
- Achieve quality operational objectives by contributing information and analysis to strategic plans and reviews; preparing and completing action plans; implementing production, productivity, quality, and customer-service standards; identifying and resolving problems; completing audits; determining system improvements; implementing change.
- Establish product specifications and quality attributes; writing and updating quality control procedures.
- Prepare quality documentation and reports by collecting, analyzing and summarizing information and trends including failed processes, recalls, corrective actions, and re-validations.
- Interact effectively with the Leadership Team and contribute to the continued growth and success of the Company through innovative thinking, planning, and implementation of new concepts, products, and services.
- Oversee all Quality Assurance labelling and assurance activities.
- Oversee all Quality Assurance inspection activities post manufacturing labelling and inspection activities (AQL)
- Represent analytical, labelling, and inspection activities during regulatory and customer inspections as required.
- Oversee the hold program and ensures materials are placed on hold / removed from hold in a timely manner to avoid potential incorrect or inappropriate processing of materials.
- Work with a team to ensure that the systems involved in a 503B outsourcing facility are in a state of control
- Other duties as assigned.
Supervisory Responsibilities:- Directly hire and lead a team of Analytical and Labeling Associates and Supervisors.
- Foster a positive and productive work environment, providing guidance, coaching, and mentoring as needed to achieve a culture of excellence and collaboration.
- Conduct regular 1:1'sto address performance, feedback and relationship building.
- Identify training and development needs within the team and facilitate as able.
Experience and Necessary Skills:- Bachelor's degree in a related field (preferably in a scientific discipline) or equivalent experience.
- 4+ years of experience working in an FDA-regulated environment, minimum of 3 years of management experience.
- Strategic and analytical thinker, with the ability to examine details and interpret the impact of key business drivers or potential adverse issues.
- Demonstrated knowledge and experience with US FDA cGMP, preferably in a commercial compounding outsourcing facility.
- Superior problem solving and decision-making skills.
- Team player with the ability to build relationships and work collaboratively across lines of senior leadership and other team members as appropriate.
- Knowledge of compounding techniques, controlled environments, and appropriate materials and conditions.
- Highest level of integrity and good judgement, with the ability to effectively deal with highly sensitive, confidential information.
- Demonstrated commitment to sound business ethics and corporate responsibility.
- Excellent organization and detail orientation.
- 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.
- Must have 20/20near range vision and proficient color perception, with or without correction, 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.
