Kelly Services Quality Control Manager - Pharmaceuticals/Sterile Injectibles in North Charleston, South Carolina

1st Shift Role - Located in North Charleston, SC - Relocation Assistance Offered! We are seeking a candidate with great leadership abilities!

Kelly Services is currently hiring a Quality Control Manager for a DIRECT HIRE position in North Charleston, SC. This is a full-time role with benefits and relocation assistance .

The Quality Control Manager is accountable for driving results in a fast paced environment, continuously challenging performance in regards to quality standards, systems and operating procedures and manages the Analytical group for the parenteral site. Responsibilities include the technical oversight of compendia and non-compendia testing and technical writing.

WHAT YOU NEED TO KNOW:

  • This role with have 9 Direct Reports

  • Must have knowledge of raw material, in-process and finished product testing, e.g. ID, appearance, cleaning methods, HPLC, TOC, conductivity and osmolality (or some combination).

  • MUST have cGMP, Pharmaceutical, serial manufacturing, injectable and CMO/CDMO experience

  • Must have 3+ years of Lead/ Supervisor experience

  • Must have a strong background in pharmaceutical quality control

Essential Functions

  • Monitors equipment/instrument operating practices and conditions to minimize equipment down time, lower maintenance costs, reduce time to run project and repeat of work.

  • Monitors quality of the group and optimizes efficiency of the work environment.

  • Provides technical support including method transfer, suitability, and verification activities.

  • Provides troubleshooting support as needed.

  • Oversees execution of analytical testing including routine analysis, method transfer, or method verification as needed.

  • Ensures adherence to department, site and corporate SOPs and other regulatory requirements.

  • Conducts investigations individually and in conjunction with clients.

  • Effectively communicates with clients and internal groups.

  • Participates in Quality audits as requested.

  • Responsible for the selection, training and development, coaching/mentoring, engagement, retention and performance management of a high performing team to meet the current and evolving needs of the site.

Education and Experience

  • Bachelor’s degree in Chemistry, Biology, Microbiology or related field of scientific study required.

  • 5+ years of related pharmaceutical laboratory experience in a cGMP environment required.

  • 3+ years of supervisory or lead experience required

  • Prior CMO or CDMO experience required.

  • Prior experience in method development/validation and/or transfer/verification, protocols, and troubleshooting required.

  • Expert knowledge of cGMP.

  • Knowledge of pharmaceutical analytical testing, and quality principles in a cGMP environment.

  • Knowledge of raw material, in-process and finished product testing, e.g. ID, appearance, cleaning methods, HPLC, TOC, conductivity and osmolality (or some combination).

  • Superior documentation skills and thorough understanding of client management.

  • Excellent leadership, communication and presentation skills.

  • Excellent skills in strategic planning, problem solving, root-cause analysis and critical thinking required.

Supervisory Responsibilities

  • Directly manages a team, typically up to 8 direct reports.

  • Participates in the hiring process of other employees.

  • Makes hiring decisions of other employees.

  • Schedules and review the work of other employees.

  • Ensures relevant curriculum assignment and timely completion of training of employees to meet regulatory requirements.

  • Coaches, mentors and develops other employees.

  • Prepares and delivers performance evaluations of other employees.

  • Makes recommendation of disciplinary actions of other employees

Apply today for immediate consideration!

Why Kelly ® ?

With Kelly, you’ll have access to some of the world’s highest-regarded scientific organizations—providing you with opportunities to work on today’s most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits you’ll be proud to help advance. We work with 95 of the Fortune 100™ companies, and found opportunities for more than 9,000 scientific professionals last year.

You pursued a career in science to fuel your quest for knowledge and your desire to make the world a better place. Let Kelly fuel your career—connect with us today.

AboutKelly Services ®

As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2017 was $5.4 billion. Visit kellyservices.com and connect with us on Facebook , LinkedIn and Twitter .

Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females, Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is committed to employing a diverse workforce. Equal Employment Opportunity is The Law.