Manager, Off Shift Quality Control

Job Description

Are you looking for an exciting opportunity with a rapidly growing pharmaceutical manufacturer? If so, then this is the opportunity for you!

Our Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements.  Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network committed to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.

Under the direction of the Associate Director, is responsible for providing guidance and supervision to hourly employees to complete testing and testing support activities.  Responsible to motivate, train and resolve problems for his/her team while maintaining a compliant and safe environment.  Uses team work and good communication skills to administer personnel policies in accordance with the local bargaining agreement.

Additional Responsibilities

• Activities involved in conducting testing and/or assaying of, validation, raw material, process intermediates and finished product samples, and is knowledgeable in the analytical techniques for the laboratory(s) they support | Technologies include those in the disciplines of, Virology, Biochemistry or other Biological Sciences

• Supervision of hourly employees performing testing which includes scheduling of work assignments based on priorities, being knowledgeable of cGMP, administration of local bargaining agreement, company personnel policies, OSHA requirements and company safety procedures

• Promotes teamwork and open communication

• Updating SOPs, Process Specific Training Modules, Test Methods, etc.

• Training personnel to ensure employees are competent and qualified to perform duties, while complying with departmental policies and procedures

• Conducting lab work accurately and in a timely fashion | Critically evaluating data generated and recommending acceptance or rejection of samples 

• Maintain records, develop productivity improvement plans, maintain adequate inventory of supplies, training records, tracking functions such as corrective actions, special projects, etc.

• Cooperates with our Company Manufacturing Division as required to resolve technical problems

• Supports deviation investigations, out-of-trend results, and test failures associated with product manufacture, release testing, and stability testing

• Investigating safety and environmental incidents and near misses | Model a safe and compliant culture throughout the laboratory

• Improve laboratory quality and to continuously improve assays using lean principles | Support regulatory inspections and train Laboratory Operations managers and/or technicians

Education Requirements

• Bachelor degree in Biology, Microbiology, Virology, Biochemistry, or associated field

Required Experience and Skills

• Minimum three years of post-degree laboratory, manufacturing, or quality control

• Principled, good and strong verbal and written communications

• Work in a Team setting

• Good interpersonal and supervisory skills

• Demonstrated ability or aptitude for continuous learning and analytical problem solving

Preferred Experience and Skills

• Biological assays and/or biochemistry based assays

• cGMP regulations

NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing