Quality Assurance Lead for GMP Biopharma

Simtrabps; Bloomington (IN); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Day One Benefits

Medical & Dental Coverage

401(k) Retirement Savings Plan with 1:

Time Off Program

Education Assistance Program

Employee Ownership Plan

Onsite Campus Amenities

Job summary

Simtra BioPharma Solutions in Bloomington, IN is seeking a Quality Supervisor to join the QA Leadership Team. You will supervise Environmental Monitoring, QALO and Manufacturing to ensure finished products meet specifications, while guiding cross-functional teams and driving regulatory compliance and Simtra SOP adherence on the production floor.

You will lead training, investigations, deviations, and continuous improvement projects, ensuring Safe, efficient operations and a strong quality

Qualifications

• Bachelor’s degree (preferred science discipline) and 2 years of Pharmaceutical Quality/Manufacturing or other GXP regulated industry experience, or Associate’s degree with at least 3 years of Pharmaceutical Quality/Manufacturing or other GXP regulated industry experience, or no degree with at least 5 years Pharmaceutical Quality/Manufacturing or other GXP regulated industry experience.
• Minimum of 2 years of leadership experience.
• Working knowledge of FDA CFR 210,211 and other applicable regulations, and Good Documentation Practices (GDP) required.
• Experience with environmental monitoring preferred.
• Familiarity with isolator filling machines highly preferred.
• Knowledge of aseptic manufacturing processes are required.
• Good interpersonal/communication/influencing/negation skills.
• Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: D365, Blue Mountain, Veeva, etc.)
• Strong technical, analytical, and problem-solving skills.

Responsibilities

• Able to successfully perform all the primary responsibilities of EM and QALO personnel.
• Effectively grows, manages, develops and empowers personnel including hiring and evaluation of performance.
• Provides rapid, quality-first decision-making in collaboration with manufacturing and other cross-functional teams.
• Ensures training and compliance of QALO associates and Quality Technicians.
• Authors and approves investigation/deviation reports.
• Leads ongoing daily QALO and environmental monitoring activities and assist other cross-functional areas to ensure successful execution/implementation.
• Ensures tasks are completed assigned to self and QALO personnel to ensure Quality and site metrics are met.
• Author, revise, and review, written standard operating procedures (SOPs), batch records, and other documentation as needed to meet Corporate, Plant, Regulatory Requirements, etc. while supporting continuous improvement initiatives.
• Ensure compliance with all federal, state, local and company-specific regulations related to quality of product and employee safety.
• Participate and lead multiple process/product improvement projects or other focus groups, design of experiments, validations, development of new methodologies or improving existing methodologies, data generation, report development, and presentation.
• Lead audit ready status efforts for assigned areas and assist other areas within the facility in understanding regulatory and Simtra quality requirements. Maintain a high level of expertise in current regulatory requirements.

Skills

Leadership

Regulatory knowledge

Interpersonal/communication

Problem-solving

Office software

Aseptic manufacturing knowledge

Education

Bachelor's degree in science

Associate's degree

No degree with 5+ years experience

Tools

D365

Blue Mountain

Veeva

Microsoft Word

Microsoft Excel

Microsoft Outlook

Job description

Simtra BioPharma Solutions in Bloomington, IN is seeking a Quality Supervisor to join the QA Leadership Team. You will supervise Environmental Monitoring, QALO and Manufacturing to ensure finished products meet specifications, while guiding cross-functional teams and driving regulatory compliance and Simtra SOP adherence on the production floor.

You will lead training, investigations, deviations, and continuous improvement projects, ensuring Safe, efficient operations and a strong quality