Surmasis Pharmaceutical- Quality Lead II |Mon-Wed 7am - 7pm | $20.00 per hour

Job Description

Job Description

SUMMARY

The Quality Lead ensures that all products are manufactured in accordance with current Good Manufacturing Practices (GMP) and meet all internal specifications. This position will spend the majority of its time in the Surmasis cleanroom/manufacturing areas providing oversight and guidance to manufacturing personnel in the performance of their duties. This position is also responsible for performing a number of quality assurance checks on in-process products and finished goods. This position is responsible for reviewing documents to ensure that they were completed in accordance with current GMP and site SOPs. Strong organizational skills and the ability to prioritize work and respond to customer demands in a timely fashion are critical requirements of this position.

Responsibilities include leading department employees to complete assigned duties in a timely manner while working safely as an effective member of the team. Leads must have good math skills, an attention for detail and the ability to work independently with minimal supervision. The Lead must also ensure accurate completion of associated documents and records. Requires the ability to direct and train employees as well as monitor multiple processes simultaneously.

  PRIMARY DUTIES AND RESPONSIBILITIES

1. Leads a team of people by example in the areas of attitude, work quality, work ethic, dependability, and communication.
2. Supports batch manufacturing activities by performing quality verifications and sampling plans.
3. Reviews documents to ensure they meet GMP and site SOP requirements.
4. Identifies, investigates, and prepares reports on quality issues.
5. Performs line clearance, inspections, and physical testing in manufacturing areas.
6. Interprets generated data and communicate results to Quality management.
7. Maintains effective communication and partnership with manufacturing and quality systems department.
8. Maintains quality standards in all tasks performed.
9. Adapts to changes in the work environment and must be able to change shifts or work overtime and/or weekends as needed.
10. Handles fast pace working environment which may require switching between multiple manufacturing rooms within a single day.
11. Leads employees and provide direction to complete required tasks.

• Follows applicable procedures, instructions, engineering drawings and training.
• Trains employees according to departmental training requirements
• Monitors employees in their jobs and assist as necessary.
• Answers employee questions involved with the Lead’s respective area.

1. Interfaces with supervision and/or management to ensure assigned duties are completed accurately. This may include interfacing with employees in other departments.
2. Works as an effective member of the team.
3. Ensures area is clean, organized and well maintained.
4. Completes all documents and records required.
5. Participates in investigations on non-conforming product, as necessary.
6. Raw material receipt verification, sampling, and CofA generation.
7. Raw material kit verifications for kit going to/from manufacturing room.
8. Maintains 5S, especially regarding cleanliness and organization of work cell.
9. Trains and mentors other leads.
10. Reads, follows, and understands standard operating procedures.
11. Other duties and responsibilities may be assigned as required.

AUTHORITY

1. Trains lower-level employees in the Lead’s respective area.
2. Interfaces with other departments as necessary.
3. Works on continuously improving the organization and function of the department by suggesting procedural improvements.
4. Stops manufacturing line should a quality defect be identified and need addressed.

 

QUALIFICATIONS

1. High school diploma or equivalent required.
2. Able to lead and influence others by example in the areas of attitude, work quality, work ethic, dependability, and communication.
3. Able to read and understand the product criteria on engineering drawings.
4. Able to direct and train employees.
5. Able to supervise multiple activities or jobs simultaneously in an accurate manner.
6. Able to work and communicate well with others.
7. Able to read and write English.
8. Good work attendance and dependability.
9. Excels in working independently and maintaining self-motivation to complete work.
10. Knowledge of various controls and procedures such as error rates, shortages, and cycle counting.
11. Must be able to work with minimal supervision.
12. Must be able to pass a background check.
13. Must be able to complete a position assessment test.

PHYSICAL DEMANDS

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is frequently required to stand, walk, sit, and operate a computer. The employee is regularly required to use hands to grasp, finger or handle objects and reach with hands and arms. The employee is frequently required to talk and hear. Specific vision abilities required by this job include close vision, distance vision, and color determination. This employee must occasionally lift and /or exert force from 25 up to 75 pounds. Push and/or pull up to 300 pounds.

WORK ENVIRONMENT

Majority of time spent working in the manufacturing floor.

Benefits:

At Surmasis, we’re proud to offer a comprehensive benefits package, including:

• Medical Insurance – PPO & HMO plans
• Dental and Vision Coverage
• Flexible Spending Account (FSA)
• Life Insurance Options
• Short-Term and Long-Term Disability (STD/LTD)
• 401(k) Retirement Plan