Under direct supervision of the QC supervisor; performs laboratory analyses for commercial and R&D product release, raw material release, stability study, cleaning verification and method validation.
Essential Duties and Responsibilities:
- Conducts routine laboratory analyses such as finished product testing, stability testing, raw material testing, cleaning verification testing and manufacturing in-process testing. Perform method qualification, verification or validation occasionally. Typical activities may include buffer/solution preparation, standard preparation and operating analytical instruments such as HPLC, UV-Vis, FT-IR, GC and dissolution tester, melting point apparatus, viscometer, Karl Fischer titrator, pH meter and analytical balance and etc.
- Work as a substitute for the QC supervisor, if necessary.
- Troubleshoot instrument problems under occasional supervision.
- Responsible for training of junior staff.
- Train junior staff in troubleshooting skills.
- Proactively provide supervisor with suggestions on how to prevent analytical error by improving the methods, lab practice or lab system.
- Conduct laboratory investigation and prepare laboratory investigation report under supervision.
- Perform notebook review to ensure accurate documentation.
- Alert to and detect abnormalities occurring during performances of tests and reviews.
- Guide junior staff in good documentation practice.
- Reports to supervisor immediately regarding OOS results and deviation from established testing procedures. Do not retest samples or re-measure samples on own decision where results are questionable.
- Keep the training record related to the job functions up to date and making sure one has received proper training before performing any tests.
- Provide general laboratory support; such as routine instrument cleaning/preventative maintenance/calibration, sample receiving, chemical inventory, document filing and housekeeping.
- Cleans laboratory working surfaces and dispose of any excess chemicals, solutions, solvents, etc. in the special waste containers for each class of waste chemicals.
- Follow all applicable safety and standards guidelines, such as company’s SOP, cGMP, DEA regulations good documentation practice and/or MSDS.
- Performs related duties as assigned.
Job Requirements :
- Number of exempt employees supervised: 0
- Number of non- exempt employees supervised: 0
Education and or Experience:
Competencies: To perform the job successfully, an individual should demonstrate the following competencies:
- Bachelor of Science Degree in chemistry, biology, biochemistry or equivalent education background from an accredited college or university is acceptable.
- 4+ years of pharmaceutical laboratory experience is preferred.
- 4+ years of hands-on experience in analytical instruments such as HPLC, UV-Vis, FT-IR, GC and dissolution tester, melting point apparatus, viscometer, Karl Fischer titrator, pH meter and analytical balance and etc.
- Seasoned in wet chemistry techniques.
- Advanced knowledge in software such as Waters Empower, Agilent ChemStation and Sotax WinSotax.
- Advanced working knowledge of applicable safety and standards guidelines, such as SOP, cGMP, GLP, DEA regulations and/or MSDS.
Physical Demands / Work Environment: The physical demands/work environment characteristics described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Leadership - Exhibits confidence in self and others; Inspires and motivates others to perform well; effectively influences actions and opinions of others; Accepts feedback from others; Gives appropriate recognition to others.
- Analytical - Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data; Designs work flows and procedures.
- Technical Skills - Assesses own strengths and weaknesses; Pursues training and development opportunities; Strives to continuously build knowledge and skills; Shares expertise with others.
- Teamwork - Balances team and individual responsibilities; Exhibits objectivity and openness to others' views; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Able to build morale and group commitments to goals and objectives; Supports everyone's efforts to succeed.
- Organizational Support - Follows policies and procedures; Completes administrative tasks correctly and on time; supports organization's goals and values; Benefits organization through outside activities; Supports affirmative action and respects diversity.
- Quality - Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality.
- Quantity - Meets productivity standards; Completes work in timely manner; Strives to increase productivity; Works quickly.
- Safety and Security - Observes safety and security procedures; Determines appropriate action beyond guidelines; Reports potentially unsafe conditions; Uses equipment and materials properly.
- Adaptability - Adapts to changes in the work environment; Manages competing demands; Changes approach or method to best fit the situation; Able to deal with frequent change, delays, or unexpected events.
- Dependability - Follows instructions, responds to management direction; Takes responsibility for own actions; Keeps commitments; Commits to long hours of work when necessary to reach goals. Completes tasks on time or notifies appropriate person with an alternate plan.
- Initiative - Volunteers readily; Undertakes self-development activities; Seeks increased responsibilities; Takes independent actions and calculated risks; Looks for and takes advantage of opportunities; Asks for and offers help when needed.
- Excellent verbal and written communication skills.
- Attention to details and accurate record keeping.
- Establishing and maintaining cooperative working relationships with others.
Offer Relocation :
- Incumbents are subject to extended periods of sitting, standing and walking; use hands to finger, handle, or feel objects, tools, or controls; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl; talk or hear; and taste or smell, looking at monitor, moderate noise levels and some business (international) travel. Work is performed in an FDA and DEA regulated pharmaceutical laboratory environment with risk of exposure to various chemicals. Minimum lifting ability of 20 lbs.
- Must occasionally lift and/or move up to 25 pounds. Wearing lab coat and safety glasses are required in the work environment.
- Specific visions abilities are required by this job include close vision and color vision.
- The noise level in the work environment is usually moderate.
- The work environment is representative of a group laboratory environment.
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