OVERVIEW
We are currently searching for a skilled professional to join a well-known clients team as a Manufacturing Technician I in Fremon, CA. The Manufacturing Technician I role will . Their work will have a direct impact on the organization and the larger clinical industry, making this an amazing career opportunity.
RESPONSIBILITIES
Executes fundamental unit operations in Downstream manufacturing related to the manufacturing of bulk drug substance in a multi-product facility. Performs duties under limited supervision and according to standard operating and manufacturing procedures.
Executes independently with adequate training non-complex fundamental operations as parts cleaning, weigh and dispense, equipment prep, kits assembly, and staging. Performs internal support duties including stocking consumables/materials, updating controlled SOP binders, appropriately discarding expired reagents, recognizing, and reporting process and equipment anomalies. Executes with oversight of qualified staff fundamental tasks as CIP and SIP of tanks, manufacturing equipment as well as buffer prep and transfer into tanks and bags Daily analytics and maintenance of analytical equipment. Cleaning and setup of equipment. Documents work according to cGMP and cGDP. Adheres to established regulations and follows cGMP established by site. Reports abnormalities and deviations in a timely and accurate manner. Adheres to safety standards and identifies unsafe situations / habits and escalates appropriately. Maintains production areas according to predefined standards (5s).
Skills:
Working in a highly regulated environment following all applicable SOPs, OCPs and BGSs for cGMP, EHS and Compliance policies. Required to work according to given schedules in a 24/7 shift structure and flexibility to adapt working schedule upon prior given notice. Low to moderate - strong focus on execution of repeatable tasks with moderate technical complexity. Performing highly proceduralized tasks. Basic interactions Manufacturing Cell Culture, Manufacturing Purification, Manufacturing Compliance, Engineering & Technology, Supply Chain, Quality Assurance, Quality Control Does not require extensive technical knowledge of manufacturing operations. Low impact, repeatable, highly proceduralized.
EXPERIENCE
Preferable 1 or more years of experience in cGMP regulated industry -Ability to concentrate on detail oriented work in a complex technical setup with a Quality and Right the first time mindset. -Strong written and verbal communication skills. -Ability to work with computer-based systems. -Ability to read and understand SOPs and work instructions and document work in a written format applying cGMP standards. -Ability to work as part of a high performing team and collaborate effectively with staff.
Education:
High school degree, entry level position. Associates/bachelors degree or biotechnology vocational training preferred.
To be a best-fit your strengths must include:
Strong Communicator. You will have extensive correspondence that relies on you being conversant in regulatory guidelines and clinical terminology.
Organized. Youre an efficient time-manager and can handle the pressure of meeting multiple strict deadlines.
Ability to work independently and with a team: You will be collaborating and often contributing to discussions amongst internal teams; you also work effectively without a lot of support or structure.
Problem-Solvers. As an action-oriented self-starter, youre eager to apply your expertise in diagnosing inefficiencies, determining root causes, and recommending solutions to complex challenges.
Personable. You establish and nurture highly effective relationships with colleagues and key stakeholders that support and advance project goals and objectives.
Credible. Thorough understanding of clinical methodologies and providing sound analytical support, you quickly establish credibility as a reliable resource.
About Advanced Clinical
Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribunes Top Workplaces, Chicagos Best and Brightest Companies, and Best of Staffing Talent & Client, visit http://www.advancedclinical.com.
Regarding your application
Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately.
It is Advanced Groups practice not to discriminate against any employee or applicant because of sex, race, color, age, national origin, religion, gender, gender identity/expression, sexual orientation/sexual preference, pregnancy/maternity, genetic information, marital status, physical/mental disability, medical condition, military/veteran status, or any other basis protected by applicable federal, state, or local law. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter so that we can discuss the appropriate alternatives available.
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