Supervisor, Quality Assurance

Minaris • Allendale, NJ

14h • Onsite

About The Position

Position Summary The Supervisor, Quality Assurance is responsible for providing quality oversite to Quality Assurance team according to Minaris Quality policies, procedures, and standards. Provide oversite for material releases, final product releases; as well as assists Quality management with department needs. He/she exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. He/she helps the team understand performance targets and goals. Ensuring that workers are properly trained for their specific roles. Coordinating job rotation and cross-training. Essential Functions and Responsibilities Provide oversight of QA floor support team. Supervise, prioritizes, and coordinates the daily activities of the QA staff within the department Facilitates internal training on quality assurance requirements, processes, and procedures. Provides technical expertise to the client services team on tech transfer activities.Must have knowledge in investigations, CAPA, change control and complaint process.Manage Batch issuance and Batch Record Tracking System.Review and approve Minaris SOPs, WIs, and Forms. Supports QA teams with continuous improvements initiatives to enforce quality culture.Initiate critical change control as required.Assist gathering information for internal and external (e.g. cGMP, client, regulatory agencies) audits. Support walk-thru in preparation for internal and external (e.g. cGMP, client, regulatory agencies) audits. Regular and reliable attendance on a full-time basis. Responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company’s policies and practices.Embodies Minaris Advanced Therapies values and aligns daily actions with department and company culture. GXP training SOP & WI training Safety Training Leadership Responsibility Supports a diverse and inclusive culture and workforce, ensures compliance with laws, regulations, and company policies. Identifies, recruits, and retains top-notch talent. Sets performance standards and encourages employee engagement through delegation, continuous feedback, goal setting and performance management.Develop employees to meet both their career and organizational goals.Builds strong customer relationships and delivers customer-centric solutions.Maintains transparent communication, appropriately communicates organizational information through department meetings, one-on-one meetings, email, and regular interpersonal communication.Comfortable working in ambiguous situations and adaptable to change. Must model the highest degree of moral and ethical behavior and maintain confidential information. High degree of autonomy and strong decision-making skills. Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems for the following positions. Directly supervise the following roles: QA Associate IQA Associate II QA Associate III Knowledge, Skills & Ability Detail-oriented and organized Analytical and problem-solving skills Good written and oral communication skills Ability to multi-task and be adaptable Flexible and able to adapt to company growth and evolving responsibilities Ability to work independently and with a team Strong Project Management and organization skills Confident in making decisions on non-routine issues Education & Experience Bachelor of Science in biological sciences or other relevant field of studyMinimum 5 years’ experience in QA in a life sciences company with a strong focus in the manufacturing and/or testing of biologics. Working knowledge and technical understanding of aseptic manufacture of biologics Minimum 1-year supervisory experience. Equivalent combination of education and experience acceptableExperience in both clinical and commercial manufacturing is preferred. Experience in authoring, reviewing, and /or approving cGMP/cGTP related documents MBR, reports, SOPS. Etc. Experience in organizing teams for effective and timely completion of projects. Understanding of quality system applications, including the use of electronic applications for training, deviations, CAPA management, etc. Relevant computer skills (Microsoft Office, Outlook) Experience participating in or hosting health authority inspections and/or client audits. Quality Requirements Ensure compliance with all FDA and Worldwide Quality & Compliance regulations in all aspects of your work. Adhere to established procedures and protocols, prioritize continuous training and skill development, and uphold the highest standards of data integrity to ensure accuracy, compliance, and operational excellence. Working EnvironmentOnsite Employees: Employee will work with moderate noise level. Employee will perform tasks while experiencing numerous interruptions. Employee may travel by car and airplane to work at different locations and may occasionally be required to travel overnight. The work environment is fast paced. This position has the utmost responsibility for compliance with the rules and regulations regarding a safe and healthy work environment relative to their actions and conduct. Off-shift, weekend and overtime duties may be required. While performing the job duties of this job, the employee is regularly required to use English written and oral communication skills. Physical Requirements The physical and mental demands and work environment described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. While performing the duties the employee is: Constantly required to sit, and to reach to use computers and other office equipment Constantly stand for extended periods of time, up to four hours/time Frequently required to lift up to 40 pounds Constantly required to view objects at close and distant ranges with hand and eye coordination Frequently required to communicate with others Note: For the purpose of this summary, occasionally is used to represent up to 1/3 of the time given to the work day; frequently represents 1/3 to 2/3 of the time and constantly represents 2/3 or more of the time. Special Working Conditions Must have the ability to work in a team-oriented environment and with clients Must be able to work during the weekend, holidays and as required by the company May be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids and are expected to utilize universal precautions with all human specimens Must utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, and liquid nitrogen Must be able to handle the standard/moderate noise of the manufacturing facility May work with hazardous materials and chemicals Disclaimer The above information in this description is intended to describe the general nature and level of work performed. It does not contain nor is it intended to be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to this job. Duties, responsibilities, and activities may change at any time with or without notice.

Requirements

• Detail-oriented and organized
• Analytical and problem-solving skills
• Good written and oral communication skills
• Ability to multi-task and be adaptable
• Flexible and able to adapt to company growth and evolving responsibilities
• Ability to work independently and with a team
• Strong Project Management and organization skills
• Confident in making decisions on non-routine issues
• Bachelor of Science in biological sciences or other relevant field of study
• Minimum 5 years’ experience in QA in a life sciences company with a strong focus in the manufacturing and/or testing of biologics.
• Working knowledge and technical understanding of aseptic manufacture of biologics
• Minimum 1-year supervisory experience.
• Equivalent combination of education and experience acceptable
• Relevant computer skills (Microsoft Office, Outlook)
• Must have the ability to work in a team-oriented environment and with clients
• Must be able to work during the weekend, holidays and as required by the company
• May be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids and are expected to utilize universal precautions with all human specimens
• Must utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, and liquid nitrogen
• Must be able to handle the standard/moderate noise of the manufacturing facility
• May work with hazardous materials and chemicals
• Constantly required to sit, and to reach to use computers and other office equipment
• Constantly stand for extended periods of time, up to four hours/time
• Frequently required to lift up to 40 pounds
• Constantly required to view objects at close and distant ranges with hand and eye coordination
• Frequently required to communicate with others

Nice To Haves

• Experience in both clinical and commercial manufacturing is preferred.
• Experience in authoring, reviewing, and /or approving cGMP/cGTP related documents MBR, reports, SOPS. Etc.
• Experience in organizing teams for effective and timely completion of projects.
• Understanding of quality system applications, including the use of electronic applications for training, deviations, CAPA management, etc.
• Experience participating in or hosting health authority inspections and/or client audits.

Responsibilities

• Provide oversight of QA floor support team.
• Supervise, prioritizes, and coordinates the daily activities of the QA staff within the department
• Facilitates internal training on quality assurance requirements, processes, and procedures.
• Provides technical expertise to the client services team on tech transfer activities.
• Must have knowledge in investigations, CAPA, change control and complaint process.
• Manage Batch issuance and Batch Record Tracking System.
• Review and approve Minaris SOPs, WIs, and Forms.
• Supports QA teams with continuous improvements initiatives to enforce quality culture.
• Initiate critical change control as required.
• Assist gathering information for internal and external (e.g. cGMP, client, regulatory agencies) audits.
• Support walk-thru in preparation for internal and external (e.g. cGMP, client, regulatory agencies) audits.
• Regular and reliable attendance on a full-time basis.
• Responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company’s policies and practices.
• Embodies Minaris Advanced Therapies values and aligns daily actions with department and company culture.
• Supports a diverse and inclusive culture and workforce, ensures compliance with laws, regulations, and company policies.
• Identifies, recruits, and retains top-notch talent.
• Sets performance standards and encourages employee engagement through delegation, continuous feedback, goal setting and performance management.
• Develop employees to meet both their career and organizational goals.
• Builds strong customer relationships and delivers customer-centric solutions.
• Maintains transparent communication, appropriately communicates organizational information through department meetings, one-on-one meetings, email, and regular interpersonal communication.
• Comfortable working in ambiguous situations and adaptable to change.
• Must model the highest degree of moral and ethical behavior and maintain confidential information.
• High degree of autonomy and strong decision-making skills.
• Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws.
• Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems for the following positions.
• Directly supervise the following roles: QA Associate IQA Associate II QA Associate III
• Ensure compliance with all FDA and Worldwide Quality & Compliance regulations in all aspects of your work.
• Adhere to established procedures and protocols, prioritize continuous training and skill development, and uphold the highest standards of data integrity to ensure accuracy, compliance, and operational excellence.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level