QC Chemistry Supervisor

Nature and Scope

The QC Chemistry Supervisor works with the Associate Manager and/or Manager of QC Chemistry/Stability for the activities associated with QC Chemistry/Stability team members. This individual is responsible for supporting the day-to-day scheduling, activity monitoring, metrics tracking and reporting for their team. This individual will also support ancillary sample requests related to investigations, validation testing, or other quality control analysis needs.

This position will require training during the daytime hours for approximately 2-3 months before transitioning to the 2nd shift.

Essential Duties and Responsibilities

Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time.

• Provide day-to-day oversight, scheduling, and support for activities and paperwork associated with the QC Chemistry/Stability teams.

• Assist QC Chemistry/Stability management in running day-to-day activities of the team to ensure that all assigned tasks are completed on time.

• Train, assist, and guide members of the team on performing tasks related to the team role in a manner compliant with regulatory guidance including Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), Good Documentation Practices (GDP), and safe working practices.

• Perform thorough investigations on out of spec results obtained in the laboratory, assist in writing the investigation reports and close out open investigations on time to meet QA deadlines on documentation.

• Assists the QC Chemistry/Stability leadership team with resolving laboratory investigations and deviations.

• Maintain work areas used primarily by the team in a clean and orderly state and in accordance with SOPs and other procedural documents.

• Maintain thorough and open communication with all Quality leadership.

• Communicates all inter- and intra-group personnel and resource issues to QC Chemistry/Stability leadership.

• Communicates all schedule and deadline conflicts to QC Chemistry/Stability leadership.

• Provide status updates and metric information to the manager as requested.

• Attend scheduling meetings related to the team activities/projects.

• Perform any other tasks/duties as assigned by management.

Education Requirements and Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required.

• Bachelor's Degree in a Chemistry, Pharmaceutical Sciences, or other Scientific field, or equivalent discipline required.

• Minimum 3-5 years of experience in pharmaceutical Quality Assurance, Quality Control and/or materials management required.

• Minimum 2-3 years of supervisory or lead role experience preferred.

• Experience with chemical safety requirements, e.g., SDS, Hazard Class, PPE, etc., preferred.

• Thorough understanding of cGMP, GLP, GDP, requirements of FDA and other international regulatory agencies.

• Ability to prioritize workloads to meet required timelines and monitor multiple schedules simultaneously.

• Ability to communicate and work well with interdepartmental groups including QA/QC, Manufacturing Operations, Materials Management, and Regulatory Affairs.

• Excellent oral and written communication skills.

• Must be able to read documents in Standard English such as Standard Operating Procedures, maintenance schedules and operating manuals.

• Strong computer skills (Word, Excel, PowerPoint, and Outlook).

Physical Environment and Requirements

• Physically able to wear laboratory protective gowning and equipment, including but not limited to gowning, goggles, face shields, respirators, and protective gloves. PPE and Respirators are essential for the health and safety of employees.

• Specific vision requirements include 20/40 near vision (can be corrected with eyeglasses or contacts) and color vision.

• Employees must maintain a clean-shaven appearance each working shift to wear tight-fitting respirators properly.

• Employee must be able to occasionally lift and/or move up to 25 pounds.

Expected Salary Range:

$117,900-$125,000

The salary range, displayed is the minimum and maximum annual salary range of compensation for the role that the employer in good faith believes to be accurate at the time of the posting of an advertisement for the role. Actual compensation for the role will be based on a number of different factors including but not limited to the candidate's qualifications, education, knowledge, skills and experience.

American Regent also offers a competitive total rewards package which includes healthcare, life insurance, profit sharing, paid time off, matching 401k as well as a wide range of other benefits.

American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual…