Apex Life Sciences is seeking a Quality Assurance Technician for the Chemistry department at a growing pharmaceutical company!
SUMMARY OF POSITION:
QA Tech IV is responsible for evaluating material and product quality by performing various procedures in the chemistry lab. The QA tech IV position interacts with formulation, filling, and packaging personnel in support of those functions in the facility.
- Performs tests and assays via thorough understanding of laboratory standard operating procedures and instrumentation.
- QA tech IV should be well-versed in both major areas of chemistry testing: wet chemistry and HPLC. Predominant testing should be geared toward HPLC analysis when appropriate. Experience using Total chrom software for processing HPLC results.
- Writes and revises new and existing testing procedures, instrument procedures, and laboratory documentation procedures.
- Assists in providing laboratory with an audit ready status as compared to global regulatory agencies as applicable.
- QA tech IV will take an active role in laboratory QA functions including, but not limited to: OOS investigation, exception reporting/investigation, SOP writing/revising, external team participation, validation activities, new product introduction, records review, SOP/SM-R/specification management, and auditing.
- Performs experimental work under adequate supervision on future products and their respective testing procedures. Records and reports results and significant observations. Performs special testing and assists in instrument and process validations.
- Actively participates in training new team members on testing procedures and compliance regulations. Primary contact for initial training for lab work, documentation, and overall plant operations.
- Works in a team environment to support internal and external customer requirements.
- Will be responsible for maintaining inventory, ordering, and reconciliation of laboratory supplies OR management of the raw material reserve samples and historical chemistry documentation kept on file.
- Assists Chemistry Manager with new method training to include interaction with R&D to train and transfer methods into the Raleigh, NC Imaging laboratory.
DEPARTMENT SPECIFIC/NON-ESSENTIAL FUNCTIONS:
- Work safely in accordance with regulations, standards, and procedures and in a manner that eliminates unreasonable risk to health and the environment. Notify management of unsafe conditions or practices, unlawful activities and activities which present unreasonable health and/or environmental risk. Report all safety and/or environmental incidents to management immediately.
- Other duties as assigned with or without accommodation.
Education required/ preferred:
BS in Chemistry (preferred) or other science with General, Organic, and Analytical chemistry coursework.
Two or more years of Analytical Chemistry testing in an FDA regulated pharmaceutical environment
Experience using Total chrom software.
Ability to perform multiple tasks simultaneously with accuracy and precision. Ability to establish priorities and demonstrate leadership.
Self-motivated, energetic, enthusiastic, and team oriented
Effective communication with both team members and other plant support groups
- Position reports to Chemistry Manager.
- Communicates problems/issues to management and staff as necessary in a self-directed manner
- Receives assignments from supervision, but exercises initiative in setting priorities within a prescribed framework of tasks. Sets and acts upon priority requirements with minimal supervision.
- Interacts with internal facility and company, as well as external, customers.
- Observes and reports variations in testing results, sample conditions, specifications/procedures, analyst technique, equipment/instrumentation, processes, and any other items which may adversely affect product quality.
- Overtime and alternate hours may be assigned in order to meet deadlines and provide support during heavy production periods.
- Light industrial pharmaceutical manufacturing laboratory environment.
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.
If you feel your qualifications meet those listed above and would like to be immediately considered for this position, please send an MS Word resume and your contact information to:
[Click Here to Email Your Resumé]
Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at [Click Here to Email Your Resumé] or 844-463-6178.