Supervisor, QC Laboratory

Adare Pharma Solutions; Vandalia (OH); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Medical, dental, and vision coverage

Retirement plan with company match

Paid time off and holidays

Tuition reimbursement with no waiting期

Life insurance

Pet insurance

Flexible Spending Accounts

Disability coverage

Job summary

Adare Pharma Solutions is seeking a Supervisor, Quality Control Laboratory in Vandalia, OH. The role oversees QC lab operations, aligns resources with testing needs, and serves as the primary contact for Manufacturing and other departments on the shift.

The ideal candidate has a BS in Chemistry (5+ yrs) or MS (3+ yrs) in pharma QC/R&D, with team leadership, strong communication, and GMP knowledge. This position offers growth opportunities within a global CDMO.

Qualifications

• Bachelor’s degree in Chemistry or closely related field with 5+ years in a chemistry lab, QC or R&D in pharma.
• M.S. in Chemistry or closely related field with 3+ years in pharma QC/R&D labs.
• Experience managing a team.
• Excellent written and oral communication skills.
• Organized with exceptional attention to detail.
• Advanced knowledge of laboratory procedures, equipment, instrumentation, safety procedures and data integrity; familiarity with stability regulations.
• Ability to work independently on multiple projects in a dynamic, fast-paced environment.
• Proficiency with Microsoft Office applications.
• Ability to contribute to cross-functional teams.
• Proactive attitude to problem-solving and willingness to learn new skills.

Responsibilities

• Manage communications between shifts and management on daily QC activities.
• Coordinate with Manufacturing, Maintenance, and R&D to ensure test method coverage and data integrity.
• Support performance reviews and provide input for others’ evaluations.
• Set shift priorities and allocate work to meet deadlines.
• Audit data when necessary to ensure GMP compliance.
• Demonstrate advanced knowledge of test methods and instrument analysis; troubleshoot and maintain instruments.
• Perform complex testing of intermediates and finished products per documented procedures.
• Operate instrument software and troubleshoot software issues; report data.
• Swab and analyze manufacturing equipment per cGMP; advise on cleaning-related issues.
• Investigate Out of Specification and Out of Trend results; support deviation investigations.
• Assist management with investigations; train others on test methods.
• Train chemists on current and new test methods.
• Maintain notebooks and files compliant with GMP; peer review as needed.
• Audit laboratory data as required; participate in cost savings and process improvement projects.
• Perform other duties as required.

Skills

Team management

Excellent communication

Detail oriented

Independent work

Cross-functional collaboration

Problem solving

Education

Bachelor’s degree in Chemistry or closely related field

M.S. in Chemistry or closely related field

Tools

Microsoft Office

Job description

Vandalia, 845 Center Drive, Vandalia, Ohio, United States of America

Job Description

Our Business

Adare Pharma Solutions is a global Contract Development and Manufacturing Organization (CDMO) with locations across North America and Italy. We offer a wide range of manufacturing, packaging, and research and development services. Our clients range from growing biotech firms advancing groundbreaking clinical trials to established pharmaceutical companies producing high volumes of approved, widely used medicines.

Our Culture

When it comes to being an employee of Adare, although we are located across multiple countries and come from diverse backgrounds, we work together toward a common purpose. Supported by leadership that is experienced and highly regarded in the industry, we are paving the way for a brighter and better future by attracting top talent from both within and beyond the CDMO space.

Why Come to Adare?

Adare is Private Equity owned and poised for growth. Employees are provided with internal development opportunities to progress within the organization, enhancing their professional skills and industry knowledge through Adare’s investment in their growth.

We offer a variety of fields to embark in, including manufacturing, engineering, quality, chemistry, formulations, analytical research and development, finance, supply chain, sales, marketing, project management, human resources, and environmental health and safety. Our benefits package is highly competitive, offering medical, dental, and vision coverage; a retirement plan with company match, paid time off and company holidays, tuition reimbursement with no waiting period, life insurance, pet insurance, Flexible Spending Accounts (medical and dependent care), and disability coverage.

Benefits

• medical, dental, and vision coverage
• a retirement plan with company match
• paid time off and company holidays
• tuition reimbursement with no waiting period
• life insurance
• pet insurance
• Flexible Spending Accounts (medical and dependent care)
• disability coverage

Position

Supervisor, Quality Control Laboratory

Location

Vandalia, Ohio

Summary

The Supervisor, Quality Control Laboratory will oversee QC laboratory operations and align resources with testing needs. This position is the primary point of contact for Manufacturing and other departments for the respective shift. Perform the most complex chemical testing of intermediate and finished products according to written procedures and maintain QC instrument operation and reliability. Position requires instrument troubleshooting and method optimization to enhance lab throughput along with training others on current test methods and assists with implementation of new methods.

Responsibilities

• Responsible for managing the communication between their respective shift and other shifts as well as management concerning daily activities in the Quality Control lab.
• Responsible for managing the communication with other departments (MFG, Maintenance, R&D)
• Completes performance reviews and assist Manager in providing input for performance reviews of other personnel not on their shift
• Sets priorities for the shift and allocates work within the shift to ensure priorities are completed on time
• Responsible for auditing data when necessary
• Demonstrate advanced knowledge of various test methods and instrument analysis techniques and be proficient with all sample types and test methods. Perform more advanced troubleshooting/maintenance of the instrumentation
• Responsible for more complex physical and chemical testing of intermediate and finished products as described in the documented procedures to support product release and process validation protocols
• Demonstrate proficient ability to operate the instrument software applications, troubleshoot software and report data
• Perform swabbing and analysis of more complex manufacturing equipment in accordance with cGMP guidelines. Provide input on cleaning related issues and investigations
• Investigate Out of Specification results, Out of Trend results and deviations in accordance with cGMP guidelines
• Assist Management with writing and completion of investigation sections and product impact as required. Train others as required as it pertains to LIR/OOS procedures
• Train other Chemists on current and new test methods
• Accurately maintain notebooks and files compliant with current GMPs and internal Standard Operating Procedures. Peer review and/or audit others work as required for verification of GMP compliance
• Auditing of laboratory testing data as required
• Perform cost savings and process improvement projects as required
• Perform other duties as required

Experience, Education, and Skills Required

• Bachelor’s degree in Chemistry or closely related field and 5+ years of experience working in a Chemistry Laboratory, Quality Control or Research and Development Laboratory, in the pharmaceutical industry.
• M.S. in Chemistry or closely related field and 3+ years of experience working in a Chemistry Laboratory, Quality Control or Research and Development Laboratory in the pharmaceutical industry.
• Experience managing a team
• Excellent written and oral communication skills
• Organized with exceptional attention to detail
• Advanced knowledge of laboratory procedures, equipment, instrumentation, safety procedures and laboratory practices which also includes lab networks and data integrity practices Knowledge and application of regulations relating to product stability
• Able to work independently on multiple projects in a dynamic and fast-paced environment
• Possess computer skills including Microsoft Office applications
• Able to contribute to cross-functional teams
• Possesses initiative with a proactive attitude to problem-solving, and has a desire to learn new skills

Adare Pharma is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status.

PRINCIPALS ONLY
NO AGENCIES OR THIRD PARTIES

Vandalia, 845 Center Drive, Vandalia, Ohio, United States of America