Job description

PHARMACEUTICAL Quality Associate experience is required

Review documented results of Quality Control testing and chose disposition (i.e. release or reject) for incoming raw materials, components, and labeling, in-process materials, and finished product for the next stage of production or distribution, as appropriate. Provide quality support during the production processes including, but not limited to, room and/or equipment release, verification of calculations in batch records, comparison of approved labeling required versus labeling released to room, in-process quality checks, and providing stability and retain samples to Quality Control as necessary. Review documentation in accordance with Good Documentation Practices and provide verification of activities performed by Production and Quality Control personnel.

Special Assignments: Each QA Product Associate may be given additional responsibilities based upon their interests and career growth plans, examples of which are described below.
Investigations
Review primary documentation to include, but not limited to, specifications, certificates of analysis, and/or technical data sheets for raw materials, packaging components, and or labeling, research current and historical production batch records and associated stability data, as necessary, interview production personnel, examine production rooms, and perform other investigative activities to both identify root causes and find solutions to resolve them.
CAPA and Change Control
Prepare Corrective and Preventive Action Plans with itemized actions to verify that the proposed CAPA do not negatively impact current quality measures, ensure the boundaries of the actions include all products and/or lots with the same issue, and that the measures to be taken address root cause(s) identified in corresponding investigations. Prepare and edit Change Requests to ensure that the measures to be taken have addressed all related documents/products/lots. Manage Change Requests to confirm deliverables have been met before closing. Upon completion of changes, follow up to ensure CAPA was effective at resolving root cause(s) before closing the CAPA.
Annual Product Review
Prepare documentation as required to verify the consistency of the existing manufacturing process, identify any process and/or quality defects, and potentially discover improvements to be made to the product and/or process.
Labeling Control
Review labeling to ensure that the ingredients list and facts box correspond to the formulation, that all the applicable state and federal regulations are complied with, and/or that the physical properties conform to current packaging line capabilities, as necessary. Assist with ensuring that labeling is segregated from non-labeling components, inventory counts, and processing of labeling to and from packaging lines. Upload labeling as required by state and/or federal agencies.
Standard Operating Procedures and Training
Review and revise Standard Operating Procedures in collaboration with the Subject Matter Expert and either ensure or provide training on the revised SOP to all personnel for whom the SOP is relevant to their job functions, roles, and responsibilities.
Packaging Batch Records
Developing new packaging batch records to address issues, identified in deviations and/or investigations as impediments to producing a quality product, and the implementation and maintenance of packaging batch records.
Customer Feedback
Track, process, and document as required customer feedback into product complaints, adverse events, medical inquiries and other forms of customer issues.

Job Type: Full-time

Pay: $21.00 - $22.00 per hour

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Schedule:

• 8 hour shift

Ability to commute/relocate:

• Fort Worth, TX 76118: Reliably commute or planning to relocate before starting work (Required)

Experience:

• Manufacturing: 2 years (Required)

Shift availability:

• Day Shift (Preferred)

Work Location: One location

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