What are the responsibilities and job description for the Quality Assurance Specialist position at Randstad Life Sciences US?
One of the world’s leading companies in the fields of health and nutrition, d elivering breakthrough innovations in healthcare and agriculture. Contribute to a world in which diseases are not only treated but effectively prevented or cured, in which people can take better care of their own health needs, Join this team which is Guided by the purpose “Science for a better life”
Local Candidates only
POSITION SUMMARY
Focus is internal. Leads cross-functional teams and interfaces with external groups on tasks / assignments relating to deviation and change management. Communicates effectively and promptly at all levels of the organization, supporting department objectives and management decisions.
POSITION DUTIES & RESPONSIBILITIES
Description :
Reviewing electronic batch records, interacting with QA staff and operations staff. Identifying errors in the batch records and interacting with productions to ensure that the corrections are completed in a timely manner to support the QA release of API and drug substance batches. The role also involves picking up paper batch records from operations (paper records consist of 10% of the reviews). Assist team member in archiving the paper records. The team is an excellent, friendly group of professionals. As a team player, the role exposes the individual to wealth of knowledge that exist amongst the team members. The team members are very supportive of one another and the candidate will be surrounded by different functional area team members. This role is a vital input to supporting the release of a safe and efficacious product to the Global community.
Skills & Qualifications (education, experience) :
- Bachelor’s degree in a scientific / technical field.
- Minimum 7 years of overall experience in the biopharmaceutical, biologics, medical device or related industry, along with knowledge and understanding of cGMP concepts, and applicable US and foreign regulations.
- A minimum of four years of direct experience in Manufacturing and / or Quality in a GMP-regulated industry or an equivalent combination of education and experience.
- Must have previous experience reviewing and approving pharmaceutical manufacturing electronic and paper batch records and understand the review and approval process.
- Previous work in Quality Assurance (e.g., release) preferred.
- Proven ability as a team player and leader.
- Excellent interpersonal skills
- Must be able to listen and understand the opinions and perspectives of others while influencing without authority with internal and external customers / stakeholders regarding possible recommendations.
- Ability to work both independently and team environment.
- The ability to multitask and support changing priorities
- Strong written and oral communication skills
- Ability to assess, investigate and resolve deviations.
- Strong ability to plan and prioritize complex and conflicting objectives to meet release goals and manage multiple priorities
- In depth knowledge of GMP
