What are the responsibilities and job description for the QC Manager position at Actalent?
Description:
Seeking Quality professional well versed in current Good Manufacturing Practices
(cGMP) to lead our QA/QC Departments. Optimize the performance, teamwork and
effectiveness of the Quality department as a whole (QC & QA) to ensure the
manufacture and timely release of a quality product which meets and/or exceeds all
specifications and is compliant with FDA and other regulatory agencies and is fully
integrated with business objectives. Direct team of Supervisors, QC Lab
Chemists and QA Associates. This position reports to our VP of Quality.
QC Supervisor -
POSITION RESPONSIBILITIES:
Supervise and coach the responsibilities and activities of the personnel of the QC Lab;
conduct technical training as necessary.
Ensure the QC Lab is meeting the needs of its customers on a timely basis.
Identify lab capabilities; communicate needs.
Formulate and assure documentation of SOPs; IQ/ OQ/ PQs; validations and other
required technical information for QC function.
Review QC data and information for in-process/ final product control, and product release
for sale and delivery to customers.
Review QC data and information for product/process development and improvement,
including troubleshooting and problem solving; conduct investigations as appropriate.
Review and approve Tower’s various technical documents regarding operations, SOPs,
validations, and the like for veracity, accuracy, and precision.
Submit progress reports as requested.
Maintain laboratory, assuring all instrumentations are calibrated, validated and
operational.
Promote and ensure lab remains current with cGMPs, GLPs, Safety and Quality standards.
Skills:
hplc, hplc instrumentation, uv-vis
Top Skills Details:
hplc,hplc instrumentation,uv-vis
Additional Skills & Qualifications:
QUALIFICATIONS:
Min. 10 years’ experience in management of Quality operations (QA and QC) in
a cGMP environment.
Proven track record of partnering with production management in terms of
championing quality principles and facilitating risk-based resolutions to quality
events.
Strong leadership skills.
Science degree (Chemistry preferred) with experience and experience in lab
practices including methods development and OOS investigation and
resolution.
Strong working knowledge of Quality release activities including material and
component approval and batch record review.
QC Supervisor POSITION QUALIFICATIONS:
3-5 years experience in chemical laboratory operations; including HPLC, FTIR, AA, UVVis spectrophotometry, and wet chemical techniques.
Experience in a production environment highly desirable
1-3 years supervisory experience; ability to promote cohesiveness among team members;
coaching ability
Knowledge of cGMP.
Effective communication skills, both verbally and in writing.
Demonstrated strong problem-solving and analytical skills
Strong customer focus
Ability to integrate strategic objectives into daily operational functions (seeing the “big
picture”)
Bachelor’s degree in Chemistry or related science required.
Experience Level:
Intermediate Level
About Actalent:
Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
Salary : $45 - $55