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Miles
Km80.5

Supervisor Analytical Laboratory

Omega Management Group

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Location: Central IL, IL Posted Date: 4/9/2013 Position Type: Full time Job Code: 4266 Required Education: Bachelors Degree

Description

OBJECTIVE:  

Supervises Laboratory colleagues and the routine operations of the Quality Control Laboratory including  the scheduling and testing of samples  of Raw Materials, Drug Products, Dietary Supplements, Stability studies, and Process  and Cleaning Validation, t testing.  Ensures that all testing is performed in accordance with internal Specification and Method Documents , Standard Operating Procedures, USP/NF monographs, or other established and approved regulatory and reference guidelines and that test results are in conformance with cGMP.

RESPONSIBILITIES:

*Denotes essential functions of the position

1.   *It is the responsibility of every supervisor to actively support, enforce, and comply with current Good Manufacturing Practices; Business Conduct Guidelines; Corporate and Plant Policies/Procedures; Standard Operating Procedures; and Safety Policies.

2.   *Performs supervisory duties to include scheduling, performance appraisals, disciplinary actions, work assignments, cycle time, productivity and training of new colleagues and temporary employees.

3.   *Supervises colleagues to ensure that sampling, inspection and testing procedures are performed in accordance with established methods, Ensures that all test results are dispositioned in accordance with regulatory requirements.

4.   *Under the direction of the Manager, Laboratory Systems coordinates the development, evaluation, and implementation of new and modified analytical procedures, and SOP’s.

5.   *Ensures that laboratory activities are scheduled to meet production requirements with minimal loss of efficiency.  Confers with the Lab Manager and Production Supervisors/Managers in the event of conflicting requirements or inability to meet schedule.

6.   *Ensures that equipment and analytical instrumentation are operational, and coordinates program of performance checks and calibrations of analytical instruments.  Ensures that required services and repairs are obtained when required.

7.   *Supervises and performs periodic audits of the QC laboratory, laboratory testing, documents, and functions to ensure continual compliance to regulatory standards.
RESPONSIBILITIES CONT.:

8.   *Promptly communicates laboratory investigations, all non-conformances, inconsistent test results, product variations, instrument or equipment failures, employee relations concerns, nonstandard overtime or staffing requirements to the Manager, Laboratory Systems.

9.   *Supervises the execution of development projects and analytical technology transfers to the Laboratory. Supports product Technical Transfers to the facility.  

10.   *Supervises chromatography data systems and all other electronic laboratory systems operations to ensure Part 11 compliance.  

11.    *Provides recommendations for purchase of laboratory equipment, supplies, and services.

12.   Maintains familiarity with, and observes requirements of, current Good Manufacturing Practice Regulations, Standard Operating Procedures, and Departmental Policies and Procedures.

13.   *Promotes and maintains a positive work environment by behaving and communicating in a manner consistent with professional standards in dealings with all colleagues, management, and visitors.

14.   Performs a variety of special projects or tasks as required to meet Department and Company objectives.
                                       
ACCOUNTABILITY, SCOPE OF POSITION:

Supervision of Raw Materials, Product Release, Incoming Quality Assurance, and Stability employees and functions; Process Validation; Cleaning Validation; and Consumer Product Complaints test requirements.



Requirements

GENERAL
Detailed knowledge of the requirements of 21 CFR parts 210, 211, and 11
Strong background in HPLC/GC, ICPMS, AA operations and maintenance activities
Proficient in validation and calibration of analytical instrumentation
Technical expertise in the investigation and resolution of laboratory non-conformances
Knowledge of Quality Information Systems
Understand system-based approach to ensure compliance
Excellent verbal and written communication skills
Analytical and problem-solving skills
Mechanical ability
Mathematical ability

EDUCATION/TECHNICAL TRAINING
B.S. Chemistry or related discipline, M.S. preferred
      
EXPERIENCE   
5 to 7 years analytical laboratory experience, preferably in a pharmaceutical manufacturing environment. 5 years supervisory experience.
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