Quality Analyst I
4745 Wiley Post Way Slc, UT 84116 US
Target Pay Rate: 20-25/hr **salary will be commensurate with experience
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.
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 (SOPs), 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.
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.
- 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.
- 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)
- 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
Although this hasn't been an issue at The Planet Group, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at The Planet Group.