Quality Assurance Analyst
Posting ID: JP-001976974
Ensure cGMP and Safety standards are maintained in the QC/Production lines assigned. Main focus is to continually raise cGMP and Safety standards and reduce or eliminate unplanned deviations.
Data review for analytical test results generated by QC department for compliance with cGMP, internal SOPs and Specifications as needed
Review, Support and escalate OOS (Out of Specifications) events and deviations. Ensures Investigations are assigned to data or documentation, as appropriate prior to data verification is signed off.
Responsible to discuss data interpretation with individual analysts and elevate, if necessary, to determine data disposition.
Facilitates laboratory data or documentation corrections with analysts to ensure accuracy.
Review all QC test packets for raw materials, API, drug product and consumables. Write certificates of analysis. Execute batch release. (API and Drug Product release will stay with experienced personnel. Drug product review will stay with experience personnel).
Support in maintaining and updating relevant SOPs for data review and reporting as needed.
Support Laboratory Inspection Readiness at site in coordination with Site QA. Participate in regulatory audits.
Ensure all QC personnel are appropriately trained.
Coordination with QC on samples, testing and schedules and maintain Trend analysis.
Once Fully Trained/Experienced:
Support in Implementation and review of Data integrity and Data review controls and electronic data audit trails to ensure data integrity. (Some aspects will be for experienced personnel).
Review and approve Change Controls for commercial and products under development. (Approval is assigned to experienced personnel)
Review stability protocols/reports for commercial and R&D products in compliance with internal SOPs and Regulatory guidelines. Hands on experience with HPLC and GC including any computerized software required for the operation of the equipment or analysis of results.
Review and approval of laboratory quality events (investigations, CAPA and Change Controls) pertaining to products (under development and commercial) manufactured.
Review and approve Method Validation, Method Transfer Protocols/Reports and instrument qualification documents in compliance with internal guidelines.
Assist with any other support activities related to Quality Assurance Document Management, Equipment Management or Warehouse Management or special projects.
Backup for QA Ops will include:
Line clearance for Manufacturing processes.
Batch record and Logbook review and update trending
Work on deviations and investigations (Once fully trained)
Change control initiation, review and approval. (Approval is assigned to experienced personnel).
Ensure all Manufacturing personnel are trained.
Quality assurance, Sop, Qa, Gmp, biology, chemistry, biochemistry, cgmp, Quality control, Fda, Batch record, Audit
Top Skills Details:
Will consider someone right who recently finished their degree with a BS Degree or someone with 3+ years of experience in pharmaceutical quality. Would ideally be someone with exposure to QA Ops but looking to grow with their degree. Could be a QC person in pharma looking to make the move into QA. Fairly open to the job history as long as they meet the behavioral characteristics listed below.
Additional Skills & Qualifications:
BS Degree in Sciences (Chemistry or Biochemistry Preferred). MS Degree is acceptable
Experienced Candidates will have:
3+ years of Quality Operations or QC experience preferred in a pharmaceutical environment.
Knowledge of cGMP and experience with quality on the floor (batch record reviews, line clearances, GMP training/coaching).
Have a sound understanding of production processes, pharmaceutical cGMP, and ability to implement cGMP in daily QA Ops activities.
QA review/verification experience over QC or other QA functions
We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffing® Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at Aerotek.com.
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
Recruiter: Nicholas Samson
Phone: (314) 801-5270