Senior Quality Laboratory Analyst

Evolving Solution Services; Dallas (TX); On-site; USD 55,000 - 75,000; Full time

Job summary

Evolving Solution Services seeks a Quality Analyst I to join the Quality Unit in Dallas, TX. You will support manufacturing operations by reviewing events, testing, and ensuring adherence to cGMP requirements throughout the documentation lifecycle.

The role requires a Bachelor's degree in Chemistry or Microbiology and at least two years of pharmaceutical experience, with strong attention to detail and proficiency in Microsoft Office tools.

Qualifications

• Bachelor's degree in Chemistry, Microbiology, or related field.
• Two years of pharmaceutical experience.
• Knowledge of USP sterile and non-sterile compounding requirements and FDA guidance.

Responsibilities

• Performs analytical testing to ensure specifications are met.
• Drafts, reviews and approves documentation for change controls and lab changes.
• Analyzes process data to identify trends and corrective actions.
• Performs Environmental Monitoring of production areas.
• Reviews line clearance and setup prior to new batch.
• Provides quality approval for materials and finished products.
• Oversees MCCPMC staff to ensure cGMP adherence during compounding.
• Collects retention samples and monitors storage requirements.
• Completes other projects as required.

Skills

Analytical testing

Documentation

Quality control

Data analysis

Attention to detail

Time management

Microsoft Office

Good computer skills

Education

Bachelor's degree in Chemistry or Microbiology or related field

Tools

Microsoft Office

Environmental Monitoring equipment

Job description

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.

Quality Analyst I

Full Time Professional Dallas, TX, US

2 days ago Requisition ID: 1006

JOB SUMMARY :

As a Quality Analyst, individuals will work as part of the Quality Unit, alongside manufacturing operations, participating in activities such as reviewing and approving planned and unplanned manufacturing events, reviewing processes and suppliers against cGMP requirements, performing testing, and participating in the documentation lifecycle.

DUTIES & RESPONSIBILITIES :

• Completes incoming, in process and finished goods analytical testing to ensure all specifications are met.
• Draft, review and approve documentation for planned (change control, protocols, etc.) and unplanned (deviations, corrective maintenance, etc.) laboratory and manufacturing changes/events.
• Analyze/Review process data to assess trends and propose corrective/preventive actions.
• Performs Environmental Monitoring of production areas, including sample collection.
• Reviews line clearance and setup in production areas prior to the start of a new batch or operation.
• Provides Quality approval and acceptance, including the release of raw materials, components, and finished products/preparations.
• Provides oversight and guidance of MCCPMC staff to ensure cGMP adherence during compounded sterile preparations.
• Collects retention samples and monitors drug storage requirements.
• Completes other projects and duties as required and/or necessary.

EDUCATION / TRAINING :

• Bachelor's Degree in a Chemistry, Microbiology or related scientific field, or Equivalent years of directly related experience.
• Trained in lab testing processes and procedures.
• Knowledge of USP Sterile and Non-sterile Compounding requirements and FDA regulatory requirements (i.e. 21 CFR and FDA Guidance documents specific to Drug Manufacturing).

WORK EXPERIENCE :

• Minimum of two (2) years of pharmaceutical experience in a pharmaceutical company or quality role.
• Quality-driven, results oriented, and strong attention to detail.
• Proven organizational and time management skills.
• Good computer skills with basic knowledge of Microsoft based programs.

ADDITIONAL QUALIFICATIONS (OPTIONAL):

• Ability to work independently with little to no supervision.