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Quality Assurance Technician (Night Shift)

Location: 1 Vandalia, OH
Requisition Number: 2036

Description

Adare is a global specialty pharmaceutical company inspired to improve the lives of patients whose treatment needs are not fully addressed by current medications. We use our unique combination of experience, proprietary capabilities, and resources to create meaningful products for them.

Our entrepreneurial and performance driven culture encourages us to take risks, identify promising ideas, and see those opportunities through to completion. Our collaborative spirit and dedication to developing strong partnerships provide Adare and our partners with significant advantages in competitive markets. _

Adare is a high-growth company with a long history of success from concept through commercialization. Our ability to create differentiated drugs guides the identification and development of the novel products in our pipeline and our acquisition strategy.

JOB SUMMARY:
This position is responsible for providing quality support to the manufacturing floor, auditing batch production documentation, dispositioning intermediates and equipment after cleaning, performing in process checks, reviewing and approving incident reports, revise quality documents (e.g. SOP, protocols, methods), and ensuring adherence to cGMP.

This position works 12 hour shifts on a 2-2-3 schedule, for example working Monday and Tuesday off Wednesday and Thursday and working Friday, Saturday and Sunday then off Monday and Tuesday, etc.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

The primary duties and responsibilities of this position include the following.  Other duties may be assigned.

  • Production Support:

    • Partner with Operations employees to document incidents, and resolve other outstanding plant quality/compliance issues.

    • Provide Quality support on the manufacturing shop floor.

    • Perform assessments during operations activities to ensure all work is performed in compliance with GMP, SOP and regulatory requirements.

    • Issue batch production and cleaning records.

    • Disposition equipment after cleaning.

  • Disposition Product:

    • Review executed Production Records, Packaging Records and Analytical results for compliance to established internal procedures, methods, specifications and industry standards.

    • Resolves minor issues found during documentation review (documentation errors, missing information) as directed by SOP.

    • Conduct product release activities for intermediates.

  • Investigations:

    • Review incident reports to insure they are properly documented.

    • Work with Quality Assurance Specialists to determine if incidents need further investigation/escalation. 

    • Enter investigations into access database.

  • Projects:

    • Participates on project teams as assigned by management.

    • Propose and author departmental procedures consistent with objectives of simplification and process efficiencies/improvements which ensure ongoing compliance.

    • Completes all assigned training by target due dates.

  • Files GMP documentation.

  • Interface with all departments within the company.

  • Be an ambassador for Quality within the company.

    • Maintain professional interactions with all departments and other sites.

    • Ensure facility adherence to cGMP.

    • Work as part of the Quality Assurance team to meet company, departmental, and individual goals as outlined by management.

    • Follow other job-related instructions and perform other tasks as required.

  • Attends work on a regular and predictable basis.

  • Upholds Company policies, including the Professional Conduct Policy and Prohibition Against Harassment Policy, and the Business Ethics and Conduct Code.

GENERAL REQUIREMENTS:

All employees are required to comply with the organization’s Privacy Policy.  Failure to abide by these requirements may result in the employee’s immediate termination.

SUPERVISORY RESPONSIBILITY:

This position does not require any supervisory responsibility.

EDUCATION AND/OR EXPERIENCE:

  • Bachelor’s Degree required preferably in a related field (i.e. pharmaceutical sciences, chemistry, biology) with 0-2 years of experience in the pharmaceutical industry.

  • Knowledge in cGMP as related to records and documentation in a pharmaceutical manufacturing environment preferred

  • Accuracy and neatness of compiling documents are required.

  • Good oral and written communication skills.

QUALIFICATIONS:       

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. 

  • Audit Batch Production documentation.

  • Interface with all internal departments within the company.

  • Receive supervision as necessary.

  • Confidentiality of pertinent information is required.

PHYSICAL REQUIREMENTS:

· Physical Demands:
  The employee is required to stand, walk, push, pull, twist, reach overhead, and bend to the floor

· Visual Ability:
  The employee must have visual sharpness for reading written instructions and computer screen.

· License Required:
  Not Applicable

· Hearing Ability:
  Not Applicable

· Working Conditions:
  The employee is subject to office, production and warehouse environments

COMPANY POSITION STATEMENT:
This is not necessarily an exhaustive list of all responsibilities, duties, performance standards or requirements, efforts, skills or work conditions associated with this position.  While this is intended to be an accurate reflection of the current job, Adare reserves the right to revise the job or to require that other or different tasks be performed when circumstances change (e.g. emergencies, change in workload or technology developments).

Adare Pharmaceuticals, Inc. is an Equal Opportunity Employer – M/F/D/V

Disclaimer: We do not utilize outside recruiting, unauthorized use of company logo or email is prohibited.

Adare does not accept or acknowledge 3rd party candidate submittals or hiring manager solicitations. All staffing inquiries should be submitted to recruiting@adarepharma.com





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