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Job Description

The Quality Assurance (QA) Manager will oversee the activity of the quality assurance department and staff, developing, implementing, and maintaining a system of quality and reliability testing for the organizations processes. Ensuring the business maintains compliance with all applicable Federal, State, Local, and Industry regulations and standards.

Responsible for ensuring the Company is compliant with all applicable regulations (Local, State, Federal, OSHA and other applicable agencies) and internal policies.

Provide guidance and mentor direct reports to grow the QA department.

Develop, operate, and maintain the effectiveness of the Quality Management System, the processes/procedures; Document Control, Deviations, Change Control, Internal Auditing, and Quality Management Review.

Conduct internal audits and report results to site leadership.

Lead Process Improvement activities within the QA department and across other departments to streamline and improve existing processes to eliminate non-value-added activities.

Communicate all quality related issues and trends to site leadership and provide periodic reports on quality assurance matters.

Support regulatory inspections and draft/coordinate responses (if required) to ensure the site is compliant with regulatory requirements.

Maintain the approved supplier list and ensure all materials received and services performed are from approved suppliers and conform to specifications.

Communicates quality standards and parameters to QA team and other appropriate staff.

Reviews client/ customer feedback on processes and partner with the appropriate team if changes are needed.

SUPERVISION RESPONSIBILITIES

Hires and trains quality assurance staff

Oversee the daily workflow and schedules of the department.

Conduct performance evaluations that are timely and constructive.

Handles discipline and termination of employees in accordance with company policy.

We are a company committed to creating inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity employer that believes everyone matters. Qualified candidates will receive consideration for employment opportunities without regard to race, religion, sex, age, marital status, national origin, sexual orientation, citizenship status, disability, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to Human Resources Request Form (https://airtable.com/app21VjYyxLDIX0ez/shrOg4IQS1J6dRiMo) . The EEOC "Know Your Rights" Poster is available here (https://www.eeoc.gov/sites/default/files/2023-06/22-088\_EEOC\_KnowYourRights6.12ScreenRdr.pdf) .

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Skills and Requirements

Bilingual in English and Spanish required.

Bachelors degree in life sciences, engineering, or related field. Advanced degree preferred.

3+ years of proven experience of Quality Management experience.

Process improvement/Lean Six Sigma/Agile methodology experience preferred.

Strong working knowledge of global GMP/GLP requirements, regulations, and guidance.

Ability to work effectively with cross-functional teams

Excellent leadership, communication, and interpersonal skills.

Excellent verbal and written communication skills.

Ability to work independently and collaboratively as part of a multidisciplinary team.

Proficiency in MS Office Suite.

Excellent time management skills with a proven ability to meet deadlines.

Excellent organizational skills and attention to detail. null

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal employment opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment without regard to race, color, ethnicity, religion,sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military oruniformed service member status, or any other status or characteristic protected by applicable laws, regulations, andordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to [email protected].