Quality Auditor

Title: Quality Assurance Auditor

Location: Salt Lake City (Onsite)

Pay: $31.50

Shift: 2nd Shift Schedule M-F 2:00 pm -10:30 pm

Core essential skill sets candidates must have to be considered for the role:

1. High School Diploma or equivalent

2. Information Management: Collect, assemble, and manage information for approval or rejection of various materials and products.

3. Foreign Matter Investigations: Conduct investigations throughout the material lifecycle.

4. Retains Management: Handle receipt, log in, and management of incoming and in-house retains, including inventory and product reviews.

5. QA First Responder: Address low complexity issues on the manufacturing/packaging floor and during batch record documentation/review.

6. Investigations and Recommendations: Participate in investigations and recommend corrective actions.

7. SOPs and Document Review: Write, revise, and review SOPs, forms, and work instructions for accuracy and GMP compliance.

8. Additional Duties: Perform other related tasks as assigned.

Skills and Abilities:

• Computer Proficiency: Knowledge of MS Office, LMS, ERP systems (SAP or Oracle), and manufacturing/quality systems (LIMS, Trackwise, Qdocs).

• Self-Direction: Ability to organize and prioritize work independently.

• Communication: Excellent written and oral communication skills.

• Collaboration: Positive interaction and collaboration with co-workers, management, and external partners.

• Problem Solving: Proactive problem-solving skills with the ability to analyze and evaluate various factors.

Physical Requirements:

• Frequent: Sitting, using fingers for activities, repetitive motions.

• Occasional: Standing, walking, stooping, kneeling, crouching, twisting/reaching, grasping.

POSITION SUMMARY

This position is responsible for monitoring production operations through the use of multiple mechanisms including routine line checks, line clearance activities, in-process inspection oversight, providing general guidance and instruction to correct identified deficiencies during documentation reviews and other oversight as needed to ensure compliance with company procedures and domestic and international regulatory requirements. This position is responsible for ensuring all site and regulatory requirements are satisfied for raw materials, labeling materials, and packaging materials prior to release. This position is responsible for artwork review and approval, retain management and label issuance as needed to support operations.

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.

• Responsible for collecting, assembling, and managing information and making appropriate decisions on approval or rejection for all components, drug product containers, in-process materials, packaging materials, labeling, and drug products manufactured.

• Responsible for conducting Foreign Matter Investigations as needed for materials throughout the lifecycle of the receipt, sampling, testing, dispensing and other in-process stages of material use.

• Responsible for receipt, log in and management of incoming retains and in-house retains. This includes management of annual inventory, annual product reviews and destruction of materials which have exceeded expiry.

• Responsible for serving as a QA “first responder” for various issues that occur on the manufacturing/ packaging floor and/or during batch record documentation/review and providing directions for situations of low complexity; moderate to high complexity situations must be deferred to more senior QA personnel.

• Responsible for labeling issuance, review and/or returns; document processing including data entry, data verification and/or processing/controls of documentation.

• Responsible for participating in investigations and providing recommendations for corrective actions and prevention of recurrence.

• Responsible for writing, revising or reviewing Standard Operating Procedures (SOP’s), forms and/or Work Instructions with changes of low complexity and responsible for ensuring accuracy and GMP compliance in documents that are being reviewed such as artwork, raw material files, AQL inspection forms, and labeling.

• 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:

• Requires High School Diploma or equivalent.

• Requires a minimum of one year experience in a regulated environment such as pharmaceutical, medical device, nutraceutical, or food processing industries.

• Requires basic understanding of Good Manufacturing Practice (cGMP) and the application to a production environment.

• Associates Degree or higher (or equivalent) achieved or in process preferred.

Skills/Knowledge/Abilities:

• Computer proficiency with comprehensive working knowledge of MS Office products, Learning Management Systems (LMS), ERP systems such as SAP or Oracle and manufacturing/quality systems such as LIMS, Trackwise and Qdocs.

• Self-directed with ability to organize and prioritize work.

• Ability to communicate effectively with excellent written and oral communication skills.

• Ability to interact positively and collaborate with co-workers, management and external partners.

Problem Solving:

• Proactively works on problems 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 may proactively to recommend methods and procedures for problem resolution.

PHYSICAL REQUIREMENTS:

Frequent:

• Sitting for extended periods of time at work station or mobile equipment

• 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

• Stooping, kneeling and/or crouching

• Twisting/Reaching – turning at waist and extending hands and/or arms in any direction

• Grasping – applying pressure to an object with the fingers and palm

• Lifting – raising 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, visual inspection involving small defects, small parts and/or operation of machines (including inspection), using measurement devices and/or assembly or fabrication of parts at a distance close to the eyes.

WORKING ENVIRONMENT

• Exposure to moving mechanical parts or moving equipment

• Exposure to low to moderate noise levels or moderate to loud noise levels

• Exposure to fumes, odors, dusts, mists or gasses (non-office)

• May be required to wear personal protective equipment (PPE) as needed when in production areas (i.e. safety glasses, hearing protection, etc.)

“We are an equal opportunity employer. It is our policy to provide employment, compensation, and other benefits related to employment without regard to race, color, religion, sex, gender, national or ethnic origin, disability, veteran status, age, genetic information, citizenship, or any other basis prohibited by applicable federal, state, or local law.”