Quality Assurance Lead - Finishing (3rd Shift)

Simtra BioPharma Solutions, Bloomington, Indiana +1

The role

The Quality Assurance Lead –Packaging is a member of the Quality Assurance Leadership Team reporting directly to the Quality Manager. They provide direct support to 3rd Shift Quality Assurance (QA) Associates and Manufacturing - Packaging to ensure that finished products meet the required specifications. The supervise and lead QA Associates, who provide quality oversight in the Inspection and Packaging complex. The QA Lead - Packaging provides decision making and oversight to ensure compliance to all regulatory agency regulations and guidelines and to Simtra Standard Operating Procedures.

This position fully supports and drives quality operations on the production floor and communicates effectively with production team members, multiple levels of management, and other support departments. The QA Lead - Packaging creates an environment where teamwork, productivity, safety, identity, strength, purity and quality (SISPQ) are reflected in the finished product.

All jobs

Quality Assurance Lead - Finishing (3rd Shift)

Simtra BioPharma Solutions, Bloomington, Indiana +1

The role

What you will do

Ability to handle multiple projects and demonstrate effectiveness in team leadership, empowerment of others, task completion, decision-making and problem-solving, , deviation management. A functional understanding of FDA, Quality Systems, and GXP application is also required.
Must be able to become a Subject Matter Expert (SME) on applicable Quality procedures for Inspection and Packaging. Ensures department policy procedures align with Global and Regulatory standards.
Plans and schedules the work of QA Inspectors for required quality inspections and label control.
Interviews, hires, coaches, and develops staff. Provides guidance, support, direction and leadership through positive interactions with all personnel during daily operations. Conducts performance reviews for all direct reports, including setting performance objectives and development plans.
Achieves defined quality objectives aligned with site goals in an efficient, accurate, and timely manner.
Ensure business needs and timeliness requirements of the department are met or exceeded
Participate in or lead process/product improvement projects or other focus groups, design of experiments, validations, development of new methodologies and improving existing methodologies, data generation, report development, and presentation.
Ensure Inspection and Packaging complex is always in an audit ready state. Maintain a high level of expertise in current regulatory and client requirements.
Assists and approves validations, audits, and assessments. Authors, reviews, and/or approves deviations, CAPAs, TSSs, Bills of Materials (BOMs), Finishing Specification Sheets (FSS), and Line Records.
Manages change control activities/documentation including validation change control, work orders, holds, etc.
Tracks and trends Quality data for review and reporting.
Works closely with Production Supervision, Engineering, and Maintenance to ensure adequacy and appropriateness of resolutions to equipment issues that arise during batch processing.

What you need

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 in a leadership role.
Knowledge of inspection/labeling/packaging equipment and processes is preferred
Good interpersonal communication skills.
Working knowledge of FDA Regulations, Application of Good Documentation Practices and Good Manufacturing Practices.
Strong technical writing skills.
Strong problem-solving skills.
Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: D365, Veeva, ROBAR, etc.)

Physical / Safety Requirements

Must be able to perform physical tasks which include bending, twisting, kneeling and stooping.
Must be able to sit and stand for extended periods of time.
Must wear appropriate personal protective equipment, as applicable.
Duties may require overtime work, including nights, weekends, and Holidays.
Use of hands and fingers to manipulate office equipment is required.

In return, you’ll be eligible for[1]

Day One Benefits
Medical & Dental Coverage
Flexible Spending Accounts
Life and AD&D Insurance
Supplemental Life Insurance
Spouse Life Insurance
Child Life Insurance
401(k) Retirement Savings Plan with Company Match
Time Off Program
Paid Holidays
Paid Time Off
Paid Parental Leave and more
Adoption Reimbursement Program
Education Assistance Program
Employee Assistance Program
Community and Volunteer Service Program
Employee Ownership Plan
Additional Benefits
Short and Long-Term Disability Insurance
Voluntary Insurance Benefits
Vision Coverage
Accident
Critical Illness
Hospital Indemnity Insurance
Identity Theft Protection
Legal and more
Onsite Campus Amenities
Workout Facility
Cafeteria
Credit Union

[1] Current benefit offerings are in effect through 12/31/26

Disclaimer

This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job. It may not be inclusive of all the duties and responsibilities of the job. Simtra reserves the right to make modifications based on business requirements.

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Quality Assurance Lead - Finishing (3rd Shift)

The role

Quality Assurance Lead - Finishing (3rd Shift)

The role

What you will do

What you need

In return, you’ll be eligible for[1]

About Simtra BioPharma Solutions

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Simtra BioPharma Solutions