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Quality Assurance Manager
Pharma Search Partners, Inc.
 
Job Location: Shenandoah, IA

POSITION TITLE: Quality Assurance Manager

Key points from talk with Hiring Manager

  • BS/BA in science
  • QA leadership experience
  • Knowledge of cGMP and ICH
  • QC lab experience or background (HPLC,GC,UV-Vis,FTIR)
  • Ideally Solid dose experience
  • Some experience with Audits

BASIC FUNCTION

Manages and assures compliance with all FDA, cGMP, and regulatory quality requirements

REPORTING RELATIONS

Reports to: Director, Quality Assurance

Supervises: Selected Quality Assurance Personnel

REQUIREMENTS

  1. EDUCATION

Required: Baccalaureate degree in a science field

Preferred: Baccalaureate degree in Chemistry, Pharmacy, or Biology

  1. LICENSING/REGISTRATION/CERTIFICATION

Required: None

Preferred: Quality Assurance Certification

  1. EXPERIENCE

Required: Minimum of 5 years experience in a FDA regulated industry (Medical

Devices, drugs)

Preferred: Experience directly related to pharmaceutical solid

dosage manufacturing and quality operations

Preferred: 3 years of personnel supervision and management

  1. D. SKILLS/KNOWLEDGE AND/OR ABILITIES
  2. Capable of comprehending written regulations, especially regarding the

development, manufacturing, and distribution of drug products

  1. Thorough knowledge of cGMP regulations, USP and International Conference

on Harmonization (ICH), and an understanding of the technical,

regulatory, and commercial aspects of pharmaceutical products

  1. Demonstrated record of successful interaction with regulatory agencies

(i.e., FDA) and other internal and external auditing groups

  1. Working knowledge of LIMS systems and other QA software systems
  2. Demonstrated ability to interface effectively with senior management,

auditors and regulators

  1. Ability to use good judgment in investigating problems
  2. Skills in maintaining cooperative working relationship with other

personnel

  1. Ability to understand and apply GMP regulations as they relate to manufacturing,

QC laboratory and facility operations.

  1. Working knowledge of QC lab equipment such as HPLC, GC, UV-Vis, and FTIR
  2. Aptitude for recognizing and dealing with priorities
  3. Ability to perform statistical analysis, data evaluation, and trending
  4. Familiarity with raw materials and chemical testing
  1. Ability to perform internal and external GMP audits
  1. PHYSICAL

Body Positions: Sitting and standing

Body movements: Flexibility in all limbs, bending at the waist, walking, climbing, crawling, 30 lb. of lifting

Body senses: Must have adequate senses in order to perform the requirements of the job

  1. MENTAL
  2. Mathematics: Proficient math skills, including knowledge of basic statistical methodology
  3. Sciences: Good basic working knowledge of biological and physical sciences
  4. Language: Read, write, and speak English well enough to communicate effectively
  5. Mechanical: Minimum. Must be able to understand basic operations of chemical, physical, and biological instrumentation and

operations

  1. Spatial: Ability to observe and notice abnormal conditions
  2. Computers: Competent skills in use of computer programs
  1. G. WORKING CONDITIONS

Most work is primarily performed in an office environment, but the ability to work in

field conditions is an advantage

  1. AUTHORITY

Has the authority to take action to meet the responsibilities and perform the duties

described herein within the limitations established in the Corporate Operating

Procedures

  1. GENERAL RESPONSIBILITIES
  2. Responsible for understanding Corporate Operating Procedures, SOPs

and policies

  1. Responsible for learning and understanding relevant regulations mandated by Federal, State, local, and foreign agencies which affect the company.
  1. SPECIFIC DUTIES AND TASKS
  1. Provide quality review and approval of GxP documents (including process,

equipment, computer, and method validation) to ensure that the documents meet internal and external regulatory requirements and guidelines such as GMP, USP and ICH

  1. Manage the Customer Complaint system for both product quality and adverse event complaints
  1. Assist in the development, preparation and tracking of quality metrics

  1. Review and approve laboratory investigations (e.g., OOT and OOS), specification and test methods, and equipment qualification
  1. Independently manages review and approval of executed manufacturing records, analytical data, and associated documentation, including deviations and investigation reports related to disposition
  1. Conducts or assists in the conduct of GMP audits and other audit related activities. Ensures timely closure of corrective actions resulting from audit findings
  1. Write and revise quality systems procedures as required to maintain a state of compliance with cGMP regulations
  1. Maintain quality systems, including but not limited to change control; vendor qualification; internal and external audits; SOPs; and process improvement

9 . Define and direct corporate quality policies, qualifications, and validations.

  1. Respond in a timely manner to regulatory inspection reports, such as FDA Form
  2. Work on special projects as assigned
  1. OTHER CRITERIA
  2. Seek guidelines and direction as necessary for the duties performed.
  3. Make the best use of time during work period
  4. Assure responsibility for staying aware of policy and procedure changes
  5. Assure responsibility for the ethical and correct production of

consumable products

  1. Perform other duties as assigned by Director, Quality Assurance.
  1. SPECIAL SPECIFIC DUTIES

FINAL REVIEW AND RELEASE OF:

  1. Containers, components, closures
  2. Labels and labeling materials
  3. In-process and finished products
  1. MEASURES OF PERFORMANCE:
  2. Timeliness of project completion
  3. Efficient use of funds and resources
  4. Proper maintenance of records
  5. Maintenance and improvement of employee attitude, especially within project

Resources personnel





How To Apply:
You will be directed to another website for application instructions.
 
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