Aseptic Observer Program Lead

Simtra BioPharma Solutions • Bloomington, IN

86d

About The Position

The Aseptic Program Observer Lead is a member of the Quality Assurance Team reporting directly to the Associate Director of Quality Assurance. The Quality Manager, Aseptic Observation Program Lead, is responsible for designing and implementing quality systems and training program required to support the Aseptic Observation program, ensuring quality oversight of aseptic filling operations. In addition, the Aseptic Program Observer Lead is expected to partner with Quality Assurance Line Operations (QALO), operations leadership, training leadership, and the Contamination Control Strategy Team. The Aseptic Program Observer Lead is expected to contribute to an environment where teamwork and productivity are encouraged, and safety, identity, strength, purity and quality (SISPQ) are reflected in the finished product.

Requirements

• Bachelor's Degree in scientific or related discipline required
• Minimum 5 years of experience in a pharmaceutical or biotech industry required
• Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: D365, Veeva, etc.)
• Ability to work in sterile environment with aseptic gowning requirement

Nice To Haves

• Excellent oral and written communication skills
• Previous technical writing experience including documentation, Change Controls, CAPAs, SOP, Regulatory observation responses
• Deviation management, review and writing

Responsibilities

• Responsible for design and continuous improvement of the Aseptic Observer Program (aseptic manufacturing quality oversight)
• Responsible for improvement and standardization of the QALO training program, including incorporation of industry and regulatory intelligence
• Develop strong partnership with QALO cell teams, manufacturing training, sterility assurance, QC microbiology and other stakeholders in program
• Organize collected data from Aseptic Observer Program, analyze trends, lead cross functional review meetings, and make necessary improvements with operations leadership based on observations
• Act as member of Contamination Control Strategy team
• Present aseptic observation program data to site and executive leadership in management review forums, including trending and improvements made
• Hire, train and develop QALO trainers

Benefits

• Day One Benefits
• Medical & Dental Coverage
• Flexible Spending Accounts
• Life and AD&D Insurance
• Supplemental Life Insurance
• Spouse Life Insurance
• Child Life Insurance
• Short and Long-Term Disability Insurance
• 401(k) Retirement Savings Plan with Company Match
• Time Off Program
• Paid Holidays
• Paid Time Off
• Paid Parental Leave
• Adoption Reimbursement Program
• Education Assistance Program
• Employee Assistance Program
• Community and Volunteer Service Program
• Employee Ownership Plan
• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Bachelor's degree
• Number of Employees: 1,001-5,000 employees