Company marketing manager

Provide shopfloor quality oversight of all production, quality control and supply chain departments to ensure their practice fully adheres to cGMP, including data integrity. Ensure timely escalation to management of all applicable incidents.

Perform live review of manufacturing batch records in preparation for batch release and escalate any discrepancies immediately.

Assist functional areas with achieving timely and compliant final product disposition of the product.

Review, approve and support procedures and production/testing records as required and assist in the training of site associates.

Ensure compliance of site personnel and application of aseptic techniques and full compliance to sterile manufacturing regulations.

Support FDA/Regulatory interactions for the Indianapolis site activities and products to ensure successful regulatory submissions and inspections.

Support QA Operations as a valued business partner, with a culture of safety, quality, delivery to patients, cost, compliance and data integrity.

This position involves shift work which will be defined through site start up and commercialization readiness.

This position involves on-call shifts, if required, when scheduled.

Requirements

2+ years of experience in a GxP Biopharmaceutical manufacturing operations

1+ years of experience in a quality assurance role

Collaborating across boundaries

Functional Breadth

QA and QC experience in biotech pharmaceutical industry with environmental monitoring & cleanliness zones

Benefits

PTO 18 days (Company Policy)

Federal 6 days

Employee Healthcare we have four options; one of them we cover 100% for the employee

Life Insurance - Employee policy 100% covered by HCG

Long Term Disability Insurance - Employee policy 100% covered by HCG

Identity Theft Insurance - Employee policy 100% covered by HCG

401K - with a company match of up to 3.5%

HCG also offer 401K Profit Sharing

HCG Technical - Company Laptop provided if needed

HCG brand items Clothing, Stationery, Quarterly care packs etc.

We support our diversity, equity, inclusion and belonging efforts because we believe that by cultivating an environment where our diverse employees can share their ideas and thrive, we will be able to better serve our organization and our global customers. Our commitment is that we have an inclusive culture that values each of our employees background, by empowering our staff to feel valued, have a sense of belonging, make positive contributions to the communities in which they live and work, and be proud to be part of Horizon Controls Group.