Tris Pharma, Inc. (www.trispharma.com) is a leading privately-owned biopharmaceutical company in the U.S. with a focus on development and commercialization of innovative medicines that address unmet patient needs. We have more than 150 US and International patents including applications and have marketed several branded and generic products in the U.S., have licensed our products in the US and international markets, and have a robust pipeline of innovative products spanning neuroscience and other therapeutic categories employing our proprietary science and technology.

Our science and technology make us unique, but it is our team members that set us apart; they are the engine that fuels Tris’ passion and innovation. Tris colleagues understand the criticality of operating a successful business and take pride in the company’s success. But of equal importance to each member of the team is how we interact with one another on a daily basis. We believe in each other and we believe in respectful, open and honest communications to help support individual and team success.

The Quality Assurance (QA) Operations Supervisor works directly with the Quality and Compliance team and collaborates closely with Operations, Manufacturing, and other teams within the organization to ensure product quality standards are achieved in accordance with Standard Operating Procedures (SOPs), current Good Manufacturing Practices (cGMPs), Food and Drug Administration (FDA) standards and batch record specifications.

This is a 2nd shift position, hours 2:00pm – 10:00pm

ESSENTIAL FUNCTIONS

Primary duties/responsibilities

• Provides timely and careful review of routine and complex QA work output to assure the highest standards of quality are met or exceeded and in compliance with regulatory requirements; Escalates issues as necessary and partners with other cross functional teams (i.e., operations, manufacturing, etc.) to correct issues
• Writes, updates and/or revises SOPs and troubleshoots issues that may arise during operations/in-coming inspection
• Assists with development and writing of SOPs and investigation reports and contributes to the circulation of the documents under approved procedures
• Reports and investigates any deviations from processes or procedures; Reviews and evaluates investigations of product complaints and process related errors

• Provides scheduling, supervision and coaching to QA Inspectors (3 shifts, 24 hours/day)

• Maintains safe and clean work environment by educating and directing personnel on the use of all control points, equipment, and resources, Maintaining compliance with established policies and procedures
• Maintains safe and clean work environment by educating and directing personnel on the use of all control points, equipment and resources, Maintaining compliance with established policies and procedures

• Executes in-coming inspection of all raw material/components
• Performs in-process inspections
• Provides clearance for rooms/lines to run

• Promptly communicates with/to appropriate departments regarding complaints, product issues/variances
• Manages, mentors, coaches, and develops direct reports
• Works extra hours or weekends as required by management to meet the demands of the schedule

KNOWLEDGE/SKILLS/ABILITIES REQUIRED

Minimum education and years of relevant work experience

High School diploma or equivalent AND minimum 10 years related work experience OR Associates degree AND 7 years related work experience OR Bachelor’s degree AND minimum 5 years related work experience. Related work experience must include multiple aspects of the quality process in a pharmaceutical or biotechnology cGMP regulated environment.

Special knowledge or skills needed and/or licenses or certificates required

• Working knowledge of manufacturing procedures and federal regulations pertaining to manufacturing processes
• Working knowledge of good manufacturing systems and familiarity with regulatory and manufacturing SOPs and cGMPs
• Demonstrated ability to read and interpret documents such as safety and environmental policies, operating and maintenance instructions and procedure manuals, etc.
• Experience conducting investigations
• Hands on experience with SOP creation and modification
• Proficiency with Microsoft Office
• Excellent verbal and written communication and skills
• Ability to work independently and collaboratively, as required, in a fast paced, matrixed, team environment consisting of internal and external team members
• Analytical thinking with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines
• Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects
• Fluent in English (verbal and written)
• Ability and willingness to work additional hours as required by business needs

Special knowledge or skills needed and/or licenses or certificates preferred

• Bachelors degree
• Experience with JDEdwards

Travel requirements

0%

Physical requirements

Office/Manufacturing based position

Ability to use Personal Protective Equipment (PPE)

This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job. The job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There may be other duties and responsibilities that are considered essential but are not listed here (such as when the essential functions of the job have expanded since the job description was created or last updated). Employees holding this position may be required to perform other duties as requested by management. Reasonable accommodations will be made when necessary to enable qualified individuals with disabilities to perform the essential duties of the position, to the extent that they do not cause undue hardship.

Tris Pharma, Inc. offers a highly competitive compensation and benefits package. To build and enhance our diverse workforce, we encourage applications from individuals with disabilities, minorities, veterans, women, LGBTQ, etc. Tris Pharma, Inc. is an Equal Opportunity Employer