Aditi Consulting
Base pay range
$26.40/hr - $26.40/hr
Summary:
The QA Associate is responsible for the Quality support functions associated with the manufacturing of solid oral dosage products for a given business unit. The essential responsibilities associated with this position are oversight of the manufacturing operations (as dictated by cGMP, CFR, and SOP) through document review/approval, real‑time monitoring/approval of manufacturing activities and testing/approval of in‑process and finished product samples.
Responsibilities:
Recommend SOP and batch record changes as needed
Review proposed SOP revisions and provide feedback to management
Real‑time audit of batch records in the production suites for completeness, documentation, calculation errors and conformance to critical process parameters
Perform room and equipment clearances per procedure following cleaning conducted by production
Perform microbial swabbing of equipment and room surfaces for environmental monitoring
Maintain a full understanding of all SOPs and policies along with all cGMP and CFR guidance that are applicable to the manufacturing of solid oral dosage pharmaceutical products
Perform routine testing of in‑process and finished product samples including particle size, bulk density, moisture analysis, appearance, and AQL testing real‑time
Monitor production manufacturing areas for compliance to SOP/cGMP/batch record and safety requirements in order to identify and resolve routine errors and prevent possible deviations that affect production real‑time
Works cross‑functionally to assess impact for potential deviations and assist in identifying if an investigation is required
Initiate deviation problem reports in Trackwise for issues discovered by QA, providing sufficient detail of the incident so that a full investigation by the responsible department can be conducted
Manage quality status of WIP and finished good materials on physical inventory and in inventory system (JD Edwards)
Other assignments as needed within the scope of QA Associate training curriculum
Assist in investigations for deviations by supporting data gathering and root cause analysis
Enforcement of GMP Compliance
Promotes teamwork and good communication
Provide training and coaching to manufacturing staff as needed
Support site process improvements (training, efficiency projects, implementation of CAPAs)
Supports customer complaint investigation by performing inspection of retains and complaint samples
Qualifications:
Preferred – Bachelor’s Degree in related science or technical field in combination with 2 years prior relevant work experience
Minimum of High School Diploma in combination with 4+ years of relevant work experience in a regulated GMP manufacturing environment
Additional qualifications desired are Lean Six Sigma, ASQ certification or other professional certifications
Desired Skills:
Familiarity with basic laboratory instrumentation
Safe work habits
Basic math and computer skills
Good communication skills
Ability to follow written and verbal instructions
Able to work with limited supervision for routine tasks
Excellent documentation and handwriting skills
Proficient reading and comprehension skills
Sound decision‑making, technical and problem‑solving skills
Good time management skills
Expert technical writing and problem‑solving skills
Good Laboratory Practices
Experienced with continuous improvement techniques
Demonstrates initiative
Pay Transparency:
The typical base pay for this role across the U.S. is $26.40 - $26.40/hour. Non‑exempt positions are eligible for overtime at a rate of 1.5 times the base hourly rate for all hours worked in excess of 40 in a work week, or as required by state or local law. Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education and experience. Full‑time employees are eligible to select from different benefits packages. Packages may include medical, dental, and vision benefits, health savings accounts with qualified medical plan enrollment, 10 paid days off, 3 days paid bereavement leave, 401(k) plan participation with employer match, life and disability insurance, commuter benefits, dependent care flexible spending account, accident insurance, critical illness insurance, hospital indemnity insurance, accommodations and reimbursement for work travel, and discretionary performance or recognition bonus. Sick leave and mobile phone reimbursement provided based on state or local law.
Seniority level
Entry level
Employment type
Contract
Job function
Quality Assurance
Industries
Pharmaceutical Manufacturing
#J-18808-Ljbffr
Summary:
The QA Associate is responsible for the Quality support functions associated with the manufacturing of solid oral dosage products for a given business unit. The essential responsibilities associated with this position are oversight of the manufacturing operations (as dictated by cGMP, CFR, and SOP) through document review/approval, real‑time monitoring/approval of manufacturing activities and testing/approval of in‑process and finished product samples.
Responsibilities:
Recommend SOP and batch record changes as needed
Review proposed SOP revisions and provide feedback to management
Real‑time audit of batch records in the production suites for completeness, documentation, calculation errors and conformance to critical process parameters
Perform room and equipment clearances per procedure following cleaning conducted by production
Perform microbial swabbing of equipment and room surfaces for environmental monitoring
Maintain a full understanding of all SOPs and policies along with all cGMP and CFR guidance that are applicable to the manufacturing of solid oral dosage pharmaceutical products
Perform routine testing of in‑process and finished product samples including particle size, bulk density, moisture analysis, appearance, and AQL testing real‑time
Monitor production manufacturing areas for compliance to SOP/cGMP/batch record and safety requirements in order to identify and resolve routine errors and prevent possible deviations that affect production real‑time
Works cross‑functionally to assess impact for potential deviations and assist in identifying if an investigation is required
Initiate deviation problem reports in Trackwise for issues discovered by QA, providing sufficient detail of the incident so that a full investigation by the responsible department can be conducted
Manage quality status of WIP and finished good materials on physical inventory and in inventory system (JD Edwards)
Other assignments as needed within the scope of QA Associate training curriculum
Assist in investigations for deviations by supporting data gathering and root cause analysis
Enforcement of GMP Compliance
Promotes teamwork and good communication
Provide training and coaching to manufacturing staff as needed
Support site process improvements (training, efficiency projects, implementation of CAPAs)
Supports customer complaint investigation by performing inspection of retains and complaint samples
Qualifications:
Preferred – Bachelor’s Degree in related science or technical field in combination with 2 years prior relevant work experience
Minimum of High School Diploma in combination with 4+ years of relevant work experience in a regulated GMP manufacturing environment
Additional qualifications desired are Lean Six Sigma, ASQ certification or other professional certifications
Desired Skills:
Familiarity with basic laboratory instrumentation
Safe work habits
Basic math and computer skills
Good communication skills
Ability to follow written and verbal instructions
Able to work with limited supervision for routine tasks
Excellent documentation and handwriting skills
Proficient reading and comprehension skills
Sound decision‑making, technical and problem‑solving skills
Good time management skills
Expert technical writing and problem‑solving skills
Good Laboratory Practices
Experienced with continuous improvement techniques
Demonstrates initiative
Pay Transparency:
The typical base pay for this role across the U.S. is $26.40 - $26.40/hour. Non‑exempt positions are eligible for overtime at a rate of 1.5 times the base hourly rate for all hours worked in excess of 40 in a work week, or as required by state or local law. Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education and experience. Full‑time employees are eligible to select from different benefits packages. Packages may include medical, dental, and vision benefits, health savings accounts with qualified medical plan enrollment, 10 paid days off, 3 days paid bereavement leave, 401(k) plan participation with employer match, life and disability insurance, commuter benefits, dependent care flexible spending account, accident insurance, critical illness insurance, hospital indemnity insurance, accommodations and reimbursement for work travel, and discretionary performance or recognition bonus. Sick leave and mobile phone reimbursement provided based on state or local law.
Seniority level
Entry level
Employment type
Contract
Job function
Quality Assurance
Industries
Pharmaceutical Manufacturing
#J-18808-Ljbffr