HR business partner

The Quality Assurance Engineer, is responsible for the design, construction, validation, maintenance and overall compliance of facilities, systems and processes at the manufacturing site.

JOB DUTIES:

Quality and Compliance aspects of design working in collaboration with Engineering, technical functions, Manufacturing Operations and outside consultants and contractors to ensure that new facility is:

o Compliant with all appropriate regulations (e.g. FDA, EMEA and other major health authorities) for GMP manufacturing

o Capable of manufacturing products that are safe, effective and that meet all applied controls and specifications.

o Capable of meeting intended design goals of output volume, turnaround time and operating and product costs.

Provide strategic quality input on the translation of commercial product requirements into technical solutions that are capable of meeting defined CQAs (product Critical Quality Attributes) and CPPs (Critical Process Parameters).

Contribute to the definition of project plan, control requirements and processes to deliver the new manufacturing facility on time, to required quality and compliance standards and within budget.

Contribute to design of facility, utilities and process equipment from a Quality and Compliance perspective.

Act as Quality approver on project deliverables, as defined in the project plan.

Work with validation colleagues to define the initial asset life-cycle model and qualification and validation strategy, to ensure successful validation of the facility. Play a lead role in the planning, execution and closure of commissioning, qualification and validation activities from a Quality functional perspective.

Collaborate with MS&T to ensure products are maintained in a validated stated.

Author and/or approve Standard Operating Procedures in support of project activity and deliverables.

Acts as the Quality approver of change controls, deviations, and CAPAs required to maintain the manufacturing facility in a GMP state.

Works with supplier and Vendor Management colleagues to ensure that suppliers of goods and services for the new manufacturing facility are compliant and capable of fulfilling their contracted requirements.

Perform QA approval of major and critical investigations.

Lead and support internal self-inspections.

Other related duties as assigned.

Requirements

EDUCATION: B.S. degree, preferably in engineering, chemistry or biochemistry

• 5+ years of experience in a GxP pharmaceutical manufacturing operations
  
• 2+ years of experience in a quality assurance role
  
• Strong knowledge and experience with the application of CFRs and cGMPs and have been involved in regulatory inspections.
  
• Experience with comprehensive audit support of all internal and external audits in support of the product manufacture and launch.
  
• Experience with radiopharmaceuticals is a plus
  

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.

EDUCATION: B.S. degree, preferably in engineering, chemistry or biochemistry REQUIREMENTS: 5+ years of experience in a GxP pharmaceutical manufacturing operations 2+ years of experience in a quality assurance role Strong knowledge and experience with the application of CFRs and cGMPs and have been involved in regulatory inspections. Experience with comprehensive audit support of all internal and external audits in support of the product manufacture and launch. Experience with radiopharmaceuticals is a plus.