Qa Manager Ii Jobs

ESSENTIAL ACCOUNTABILITIES:

• Develops and manages the facility’s Quality Management System to ensure:

a. Compliance with Rockline Global quality standards
b. Product and material conformance to specifications and quality standards
c. Customer requirements and expectations are being met
d. Regulatory compliance of all areas of the operation
e. Compliance to change control requirements

• Manages Non-Conformance Program:

a. Ensures all Non-conformances are investigated
b. Follow through to make certain that root causes are identified
c. Ensure implementation of effective corrective and preventative actions

• Ensure that proper procedures and documentation required by local and federal regulatory agencies are

developed, implemented and maintained.

• Maintain and track internal environmental monitoring program.
• Acts as the Quality liaison for customers and suppliers.
• Establishing priority of daily job tasks for QA associates.
• Provides oversight for Laboratory operations by:
• Maintain ISO 22716 certification.
• Ensuring the integrity of the data and operations of the laboratories.
• Creating and maintaining a safe working environment for QA associates.
• Formulate responses to any findings from audits and issue corrective actions where needed.
• Providing proper training, performance reviews and development opportunities.
• Maintain Social compliance and sustainability certifications.
• Manage internal audit programs.
• Ensuring timely release of finished products.
• Serve as primary site contact for regulatory, customer or third-party audits.
• Responsible for internal and external audit programs.
• Oversight of quality requirements for IQ/OQ/PQ of new equipment, process and cleaning validations.
• Lead and manage performance and development of the Quality Assurance team.
• Quality contact for GMP audit of site by customer.
• Identifies and helps to implement continuous improvement opportunities in Quality and cross-functional

work processes.

• Completes Global QA projects and address Global QA inquiries.
• Lead preparations and presentation of Annual Management Review.
• Makes decisions based on regulatory requirements and communicates those decisions to management.
• Develops and executes site QA operating budget and manages department efforts to control costs within

approved levels. Provides budget status reports as scheduled or needed.

• Exercises decision-making with good judgment. Shows initiative in gaining/maintaining skills, abilities

and knowledge required to perform effectively.

• Demonstrate commitment to Rockline’s RRITE Values of Renew, Respect, Integrity, Teamwork, and

Excellence.

• Associates have a direct and important role in ensuring that all work is performed in a safe manner.

Effectiveness in carrying out this responsibility is part of each associate’s essential accountabilities.

• Contribute to a cooperative working effort by demonstrating a willingness to perform other job-related

work, as needed or requested
This position is designated as a Safety-Sensitive (A safety-sensitive position is one in which the associate’s
inability or impaired ability to perform their job-related tasks could result in a direct threat to the associate’s
safety or the safety of others).
QUALIFICATION REQUIREMENTS: (To perform this job successfully, an individual must be able
to perform each of the essential accountabilities satisfactorily. The requirements listed below are representative.
of the knowledge, skill, and/or ability required.)

• Seven years progressively complex experience in Quality Assurance, including 3 years' experience
• Bachelor of Science degree or higher in scientific field. Strong background in microbiology preferred.

supervising and managing staff in an industrial or manufacturing setting.

• Prior work experience desired in a leadership role in a GMP manufacturing environment (cosmetic,

OTC drug or device).

• Strong verbal, written, analytical and interpersonal skills. Ability to organize and prioritize workload to

meet deadlines.

• American Society of Quality (ASQ) technical certification (Quality Auditor, Six Sigma, Quality

Engineer, Quality Manager) preferred.

• Some travel to other sites up to 20%.
• Must be proficient in Microsoft Office. Understanding or Statistical Process Control desired.

PHYSICAL AND MENTAL REQUIREMENTS: (The physical demands described here are
representatives of those that must be met by an associate to successfully perform the essential functions of this
job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential
functions)

• Frequent standing/walking. Occasional sitting, bending, twisting, kneeling, climbing, pushing/pulling
• Must be able to communicate face-to-face and over the phone

and reaching

• Requires ability to read, write, calculate and analyze
• Occasional carrying and lifting up to 30 pounds.
• Requires good visual acuity with depth perception and color vision.
• Repetitive hand and foot movement.
• Ability to tolerate work environment that includes occasional noise >85db, hot and cold temperatures.