Sr. Quality Systems Engineer

Planet Pharma; Salt Lake City (UT); On-site; USD 55,000 - 69,000; Full time

Job summary

Planet Pharma in Salt Lake City is seeking an experienced QA professional to lead quality systems support, documentation management, and CGMP compliance. The role oversees change management, annual product review, and data trending, partnering across Operations, Manufacturing Science, and Quality Assurance.

You will drive Continuous Improvement projects, facilitate regulatory inspections, and ensure adherence to policies while guiding a collaborative team across internal and external

Qualifications

• Bachelor’s degree in science or related field with 7+ years pharma QA experience.
• Minimum 3 years QA in pharmaceutical production.
• Direct experience with Health Authority inspections preferred.
• Project management and advanced presentation skills preferred.

Responsibilities

• Develops and executes quality/compliance projects to improve site metrics.
• Hosts Change Control Review Board and oversees change control activities.
• Provides records management and support for compliant shutdown planning.
• Maintains CGMP compliance with SOPs and policies.
• Collaborates with operations, M-SAT, R&D, QA, and supply chain.

Skills

MS Office proficiency

LMS experience

EDMS familiarity

ERP systems

Quality leadership

Communication skills

Data analysis

Education

Bachelor’s degree in science or related field

7+ years pharma QA experience

3+ years QA in pharmaceutical production

Experience with health authority inspections (FDA/EMA/ANVISA)

Tools

Trackwise

Veeva

ERP systems

Job description

Pay range: 40-50/hr
*depending on exp

POSITION SUMMARY

This position is responsible for providing support for the quality management systems (QMS), including documentation management, Continuous Improvement program, process, cleaning and computer system validation, equipment, facility and utility qualification. The role oversees Change Management, Annual Product Review, and Metrics and Data Trending. This position ensures adherence to quality standards, policies and procedures, while facilitating improvements and building a collaborative team environment among internal and external stakeholders. This position represents Quality Systems leadership and interacts closely with other areas such as Operations, Manufacturing Science and Technology, Research and Development, Supply Chain and Quality Control.

ESSENTIAL AREAS OF RESPONSIBILITY

All areas of responsibility listed below are essential to the satisfactory performance of this position by any incumbents with reasonable accommodation if necessary. Any non-essential functions are assumed to be included in other related duties or assignments.

• Develops, supports and executes annual projects to deliver on site metrics, KPIs, goals, and other Quality / Compliance program related projects as required.
• Responsible for hosting the Change Control Review Board and overseeing change control activities from initiation through implementation and approval.
• Responsible for providing records management and change control expertise to support compliant shutdown planning and execution.
• Responsible for ensuring efficient, uninterrupted operation of the facility in accordance with requirements such as GMP, FDA, MHRA, EMEA, OSHA, EPA, DEA, etc.
• Responsible for participating in partner, internal and regulatory inspections and audits as needed.
• Responsible for reviewing and approving standard operating procedures, protocols, risk assessments and other quality records, as needed.
• Responsible for improving and maintaining quality systems to ensure compliance with CGMPs, company policies, procedures and governmental regulations.
• Supports Quality projects for accomplishment of organization goals including Corporate standard assessments, Quality project team meetings, and other cross-functional site initiatives.
• Responsible for completing all training requirements and maintaining compliance with all assignments.
• Responsible for maintaining work areas and performing job functions in a safe and efficient manner in accordance with company policies and procedures, Good Manufacturing Practices (CGMP), Standard Operating Procedures (SOP).
• Responsible for performing additional related duties as assigned.

POSITION REQUIREMENTS

Any equivalent combination of education, training and/or experience that fulfills the requirements of the position will be considered.

Education/Certification/Experience:

• Bachelor’s Degree, preferably in a scientific discipline (biology, chemistry or closely related field) or equivalent education/experience with a minimum of 7 years relevant progressive experience in the pharmaceutical industry.
• Requires a minimum of 3 years’ experience in Quality Assurance within pharmaceutical production.
• Prefer direct experience with the manufacturing of various pharmaceutical dosage forms.
• Prefer direct experience with Health Authority Inspections (FDA/EMA, ANVISA, etc.)
• Project management and advanced presentation skills preferred

Skills/Knowledge/Abilities:

• Computer proficiency with comprehensive working knowledge of MS Office products, Learning Management Systems (LMS), EDMS and ERP systems, as well as Quality systems such as Trackwise and Veeva.
• Self-directed with ability to organize and prioritize work.
• Ability to motivate, influence and lead others with and/or without direct supervisory authority.
• Ability to positively manage conflict, provide difficult feedback and negotiate resolution.
• Ability to build and maintain collaborative relationships between teams, departments and business units.
• Ability to demonstrate sound judgment and decision making.
• Ability to communicate effectively with excellent written and oral communication skills.
• Ability to interact positively and collaborate with co-workers, management and external partners.
• Ability to analyze information and create metrics relevant to the business objectives.
• Ability to understand inter‑department linkages and alignment of own department with other departments.
• Ability to drive change by identifying areas for improvement, engaging and motivating others and working through difficult transitions.

Problem Solving:

• Proactively works on problems of a complex scope where evaluation of contributing factors requires the analysis of situations or data and an in-depth knowledge and evaluation of various known and unknown factors.
• Seeks out all resources when selecting methods and techniques for obtaining results.
• Acts independently and proactively to direct method and procedure for problem resolution.

TRAVEL REQUIREMENTS

• Minimal

PHYSICAL REQUIREMENTS:

Frequent:

• Sitting for extended periods of time.
• Using fingers to perform activities such as picking, pinching or typing.
• Repetitive Motions – frequent motions of the wrists, hands and/or fingers.

Occasional:

• Standing for extended periods of time at work station or equipment.
• Walking to move short distances quickly and frequently.
• Lifting – raising objects from lower to upper and/or moving objects horizontally – up to 25 lbs.

Visual Acuity:

• Close visual acuity to perform activities such as computer work, preparing and analyzing data, extensive reading.

WORKING ENVIRONMENT:

• Frequent exposure to low to moderate noise levels.
• Occasional exposure to moving mechanical parts or equipment.
• May be required to wear personal protective equipment (PPE) as needed when in production areas (i.e. safety glasses, hearing protection, gloves, etc.).