Quality Assurance Supervisor

Job description

Quality Assurance Supervisor

The Quality Assurance Department at this site supports quality functions for Active Pharmaceutical Ingredients (APIs) under Good Manufacturing Practice guidelines (ICHQ7).

 

Your role:

Manages a team responsible for Quality oversight of custom API manufacturing according ICH Q7 and cGMP regulations. In support of site wide objectives, supervises floor support activities, reviews and may be delegated to approve area documents such as Batch Records, SOPs, deviation investigations, OOS investigations, CAPAs and Change Requests.

Coordinates Quality support of production preparation and operation. Engaged with cross functional teams as needed to support continuous improvement activities. Requires decision making ability related to Incident Investigation initiation, with emphasis on overall quality, site priorities, results and achievements.

·  Implement and execute procedures to assure compliance with regulatory requirements and internal policies.
·  Direct aspects of batch record review and release for raw and final products produced under GMP conditions.
·  Supports operational excellence and site transformational initiatives.
·  Support for processes to hire, develop, coach, reward and monitor training and communication staff members.
·  Set and implement objectives and development plans for direct staff.
·  Support communication process improvements throughout the site and enable replication of good practices between sites.
·  Support the development of project plans for specific quality system initiatives and process improvements
·  Coordinate the selection, training, development, motivation, and evaluation of employees. 
·  Evaluate employee performance against expected job requirements.
·  Mentor employees in meeting or exceeding expected job requirements, by ensuring skills and knowledge development occurs to allow employees to maximize performance
·  Implement and execute procedures to assure compliance with regulatory requirements and internal policies.
·  Direct aspects of batch record review and release for raw and final products produced under GMP conditions.
·  Supports operational excellence and site transformational initiatives.
·  Support for processes to hire, develop, coach, reward and monitor training and communication staff members.
·  Set and implement objectives and development plans for direct staff.
·  Support communication process improvements throughout the site and enable replication of good practices between sites.
·  Support the development of project plans for specific quality system initiatives and process improvements
·  Coordinate the selection, training, development, motivation, and evaluation of employees. 
·  Evaluate employee performance against expected job requirements.
·  Mentor employees in meeting or exceeding expected job requirements, by ensuring skills and knowledge development occurs to allow employees to maximize performance

 

Who you are :

 

Required Skills:

·  B.S./B.A. in Life Sciences, Chemistry, Pharmacy, Chemical or Process Engineering
·  2+ years of experience with ICH Q7
·  5+ years of progressive experience in GMP Pharmaceutical Manufacturing Environment

 

Preferred Skills:

·  Current API knowledge and/or experience desired.
·  Good computer skills, including proficiency in MS Word, MS Excel, MS Powerpoint, and the ability to learn and operate other specific application software, required
·  Excellent written and verbal communication and customer interface skills required
·  Excellent writing skills and experience writing technical documentation and reports required
·  Ability to simultaneously manage multiple tasks/priorities required
·  Good problem-solving skills/abilities required
·  Good time management and negotiating skills required
·  Capacity to work independently required
·  We are seeking a motivated individual with experience in a regulated environment.

 

RSRMS 

Job Requisition ID: 204837

Location: St. Louis

Career Level: D - Professional (4-9 years)

Working time model: full-time

US Disclosure
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law.  This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.

North America Disclosure
The Company is committed to accessibility in its workplaces, including during the job application process. Applicants who may require accommodation during the application process should speak with our HR Services team at 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday.

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