Manager Quality Control - Lab Operations at Baxalta U.S., Inc. in Social Circle, Georgia

Job Description:

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Job Description

About the role:

As the Manager of Laboratory Operations you will provide Leadership for the Operational Support functions of the Quality Control Laboratory. This role may lead a team of 10 - 15 employees at any time. You will report to the Head of Quality Control.

How you will contribute:

• Provide directions to team members using Quality Laboratory goals, general policies and management guidance related to lab operations.


• Interpret applicable quality and regulatory requirements (e.g., FDA, cGMP, USP/EP/CP), develop procedures to implement these requirements for laboratory operations.


• Work with manufacturing and technical services teams in proactive functions that impact production, increase efficiency, solve problems, produce cost savings, and improve quality.


• Assure compliance with company procedures. Prepare the department for an audit by authorities. Be the Quality Management backup person for the QC Lab and partner with investigators during inspections.


• Assure a safe and non-discriminatory working environment for employees.


• Assure employees are trained and audited. Make appropriate staffing recommendations. Evaluate performance with performance appraisals and insure employees have development plans.


• Work with teams of departments and meeting operational goals.


• Provide Leadership for Laboratory Services Teams to include establishing customer expectations between Takeda and any Third Party providers that may support the Covington QC Lab


• Manage the Laboratory Systems Administration, Metrology Team, Analytical QC Lab Training program and Document Control


• Support the Quality Control Laboratory Budgeting process and procurement


• Additional duties assigned by Leadership

• Bachelor's Degree in Chemistry, or biological science with >8 years' experience or Master's Degree in Chemistry, or biological science with 3+ years experience, PhD in relevant scientific field with less than 3 years' experience.


• 5 years of prior Pharmaceutical Laboratory Leadership experience


• Must know quality laboratory operations and government regulations for pharmaceutical and medical device manufacturing labs.


• Have the ability of managing complex projects and resolving complex lab issues.


• Have advanced knowledge in Statistical Analysis and cGMP standards


• Leadership, project and people management skills


• Experience with business or industry.


• May lift, push, pull and carry up to approximately 25 lbs.

• Comprehensive Healthcare: Medical, Dental, and Vision


• Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan


• Health & Wellness programs including onsite flu shots and health screenings


• Generous time off for vacation and the option to purchase additional vacation days


• Community Outreach Programs and company match of charitable contributions


• Family Planning Support


• Professional training and development opportunities


• Tuition reimbursement

At Takeda, our patients rely on us to deliver quality products. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product. In this role, you may:

• Work in a controlled environment requiring special gowning and wear protective clothing over the head, face, hands, feet and body. This may include additional hearing protection for loud areas.


• Need to remove all make-up, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment.


• Work in a cold, wet environment.


• May have to work in a confined environment


• Work multiple shifts, including weekends, or be asked to work supplemental hours, as necessary.


• Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

This posting excludes Colorado applicants.

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EEO Statement

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

Locations

USA - GA - Social Circle - Hwy 278

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time