Quality Control Supervisor in North Charleston, SC at Apex Life Sciences

Date Posted: 10/2/2018

Job Snapshot

Job Description


Seeking a Quality Control Supervisor with 6-9+ years experience in pharmaceuticals. Please contact Andy Reed for more information at 704-332-5443 or awreed@apexlifesciences.com. 

About

Our client is a world-class contract development and manufacturing organization (CDMO). A mindset of innovation, accountability and customer focus inspires us to be the most efficient, safe and reliable choice for our customers and the patients they serve.

Position Summary

The Supervisor, Quality Control is accountable for driving results in a fast paced environment, continuously challenging performance in regards to quality standards, systems and operating procedures.  The Supervisor, Quality Control leads and manages the Analytical group for the parenteral site in Charleston, SC.  Responsibilities include the technical oversight of compendia and non-compendia testing and technical writing.  The position requires strong leadership behaviors of the core competencies and non-negotiables, as well as the functional competencies of this profile.                                

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 (Chemistry, Biology, Microbiology or related field of scientific study) required.
  • 5+ years of related pharmaceutical laboratory experience in a cGMP environment required.
  • 2+ years of supervisory experience preferred.
  • Prior CMO or CDMO experience preferred.
  • Prior experience in method development/validation and/or transfer/verification, protocols, and troubleshooting required.

Non-Negotiables

  • Consistently demonstrates honesty and integrity through personal example.
  • Follows all safety policies and leads by example a safety first culture.
  • Produces high quality work product with a focus on first time right.
  • Complies with the company code of conduct and policies and regulatory standards.

Core Leadership Competencies

  • Thinks strategically. Quickly identifies and acts on opportunities. Considers the downstream impact. Seeks to understand the why. Focuses on work that matters.
  • Develops organization and others. Takes ownership to develop self and others. Seeks out new opportunities and experiences for continuous learning.
  • Acts decisively. Makes and acts on decisions quickly. Makes decisions with the customer and their patients in mind. Meets commitments with a sense of urgency. Seeks ways to be more efficient.
  • Drives performance. Holds self and others accountable. Delivers results first time right. Never settles for status quo. Willing to have tough conversations. Asks for feedback and takes action to improve.
  • Passion for customers. Listens to understand. Asks the right questions. Gets to the heart of the matter and uses that insight to provide value.
  • Works collaboratively. Seeks out the experience of others with the aim for better results. Open minded regardless where ideas originate. Flexible and easy to work with.

Functional Competencies

  • Expert knowledge of cGMP.
  • Knowledge of method development/validation and/or transfer/verification and protocols.
  • 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.

Decision Making and Supervision Required

  • Uses professional concepts, company policies and SOPs to solve a wide range of difficult problems in effective ways.
  • Determines methods and procedures on new assignments and may coordinate or oversee activities of others.

Travel Requirements

  • Up to 5% domestic travel

#LI-AR1

EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178.




873673

CHECK OUT OUR SIMILAR JOBS

  1. Quality Assurance Jobs
  2. Qa Analyst Jobs