Work Schedule

Environmental Conditions

Job Description

Essential Functions:

1.    Serve as Quality contact and lead on resolution of incoming quality issues. Provide review and approval, where applicable, to incoming materials.
2.    Develop solutions to complex issues and Quality initiatives with inter-organizational impact. Follow cGMP regulations and company standards. 

Develop and train personnel and internal customers on relevant business processes.
3.    Serve as the Quality representative on cross-functional and multi-site teams.
4.    Lead department and cross-functional initiatives, including maintenance of the reduced testing program in collaboration with Quality Control.
5.    Troubleshoot and advise the resolution of Quality issues by fostering effective interdepartmental and cross functional partnerships.
6.    Serve as a technical subject matter expert (SME) in support of department functions. Participate as a Compliance representative in team meetings. SME on compliance issues, independently raises compliance issues with the team.
7.     Review and approve controlled documents relating to processes, equipment, facilities and utilities in the manufacture of product. Review and approve change requests.
8.    Provide guidance to internal and external customers on standard processes for maintaining
a supplier quality program (including self-audit and supplier quality)
9.    Provide technical assessment and approval for controlled document change, provide Quality oversight to internal and external customers. Provide input into the design and presentation of departmental performance metrics.
10.    Administer, document, and maintain the company's Quality Systems conformance to regulatory requirements and company policies where appropriate through effective utilization of Quality Systems and tools.
11.    Notify Management of potential quality or regulatory issues that may affect product
quality or regulatory compliance. Approve documents for activities as authorized and described by policies, procedures and job descriptions.
12.  Perform other duties as required

Education: 
Prefer BS degree in Chemistry, Biology or related scientific subject area; will consider Associate's Degree (AA/AS) with 6-8 years relevant experience.

Experience:

Prefer 2 years direct experience in regulatory affairs/Quality Assurance

Equivalency:

Equivalent combinations of education, training, and meaningful work experience may be considered

Competencies:

•    Establish work priorities to meet targets and timelines
•    Handle challenging priorities and allocate, adjust, and optimize assigned department resources

•    Sound knowledge of cGMPs or equivalent regulations
•    Ability to interpret and relate Quality standards for implementation and review
•    Ability to make sound decisions about scheduling, allocation of resources, and balancing priorities

•    Ability to communicate clearly and professionally both in writing and verbally
•    Flexibility in problem solving, providing direction, and work hours to meet business objectives

•    Knowledge of GMPs/QSRs and other relevant compendia.

•    Able to interpret and apply to operations.
•    Leads projects and works with management to acquire resourcing.