Location: Oakland, CA
Successful candidates must possess basic knowledge of public sector purchasing practices and terminology, and have strong written and oral communication skills. Additionally, successful candidates will possess the following attributes:
Job Type: Full-time
Pay: $25.00 - $30.00 per hour
A renown pharmaceutical organization located in Berkeley, CA is on the search for a Pharmaceutical Manufacturing/QC Production specialist to join their team.
The candidate in this role is responsible for the clinical manufacturing of monoclonal antibodies (mAB) drug substances within the Cell Culture Technology Center (CCTC). This candidate will be collaborating closely with biological development (BD) and Manufacturing Science and Technology (MSAT) teams for new product introductions and ensure platform alignment.
Some responsibilities include:
Qualified candidates will be contacted immediately!
An amazing opportunity to work for a global pharmaceutical corporation. This at least a 1 year contract working mainly as a Production/Plant Specialist. This position performs routine and non-routine environmental monitoring, microbiological testing of commercial and Bio-Development manufacturing and routine and non-routine chemical monitoring and basic instrumental analysis of water types and rinse samples. Performs non-routine support for validation, facility or utility maintenance, and other projects as directed by a supervisor or designate.
Key Working Relations:
• Work with cross-functional areas – including: Quality Control, Production, Supply Chain, Logistics, Procurement, QC Sample Handling Office, other QC Microbiology Labs, Production, Central Utilities, Engineering Department, Investigators.
• Follows standard operating procedures to perform routine environmental monitoring of manufacturing facilities, laboratory and utility systems at the Berkeley site.
• Perform non-routine testing to support validations, performance qualifications, maintenance/repairs, sample receipt and projects as directed by a supervisor or designate.
• Follows all good manufacturing practices and good laboratory practices, safety rules and department guidelines. Uses care and judgement in the use and handling of laboratory materials and equipment to maintain a compliant, safe, clean and orderly working environment.
• Perform documentation and other duties according to cGMP rules and regulations using test records, logbooks, or computer systems. Maintains laboratory inventory.
• Actively participate in relevant site initiatives such as: Behavior Based Safety (BBS) and Product Supply System (PSS).
• Maintain current training status for assigned SOPs, SOP revision training, GMP and HSES training. Maintain minimum eighty-five percent (85%) qualification in Curriculum.
• Performs 5S and safety audits of lab area and maintains lab in a compliant state.
• Perform other duties as assigned.
• Perform routine calibration of lab instruments and clean lab equipment
• Peer review of test results may be required.
• Receive and log samples in MODA or LIMS.
Equipment and Materials Used:
• MODA, LIMS, SAP standard laboratory equipment and instrumentation, including, but not limited to: viable air sampler, total particulate counter, Matson Garvin unit, manifolds, computers, pipettes, personal safety equipment, calculators, SOPs with detailed test records and typical laboratory chemicals.
Qualifications & Competencies:
• Requires Associate degree in Biological Sciences or an equivalent combination of education and experience. Aseptic technique and attention to detail is essential. Familiarity with a pharmaceutical, clinical or quality working environment is desirable.
• Working knowledge and understanding of cGMP and global regulatory compliance.
• Experience and competency with USP, EP, JP, ACS, FCC compendia/monographs.
• Experience working in a Quality Control environment
• Read, write, speak, and comprehend English in order to understand and follow written and verbal instructions, SOP’s, etc.
• Acceptable attendance and performance.
• Work weekends, holidays and overtime as required.
• Strong interpersonal skills with the ability to work effectively as part of a team.
• Work independently and self-directed with minimal supervision.
• Detail oriented with the ability to demonstrate good record keeping practices and ability to follow data integrity rules.
• Ability to multitask, troubleshoot, use analytical judgment to plan and perform diversified work, making decisions within prescribed limitations, and good adaptability to changing business requirements in a dynamic corporate environment.
• Work safely in an environment containing hazardous chemicals, high and low temperature liquids, high pressure liquids and gasses, steam, and moving machinery.
• Strong computer skills required.
• Familiarities with Lab management systems (LIMS) and Mobile Data Acquisition System (MODA).
• SAP (or similar software) strongly preferred.
• Follow directions, written or verbal
• Follow Standard Operating Procedures (SOPs).
• Working knowledge of cGMP and global regulatory compliance.
• Must be able to lift up to ≤25 lbs. and push/pull up to ≤650 lbs. with assistance.
• Must be able to withstand frequent repetitive movement, stooping, crouching, kneeling, climbing (ladders), and sitting.
• Must be able to wear protective clothing (PPE) as required.
• Must not have unusual sensitivity to typical lab chemicals or gloves (i.e. sanitizing agents).
• Must be able to identify color-coded labels.
• Must have good visual acuity and color perception in order to enumerate microbial growth and test using a microtiter plate.
• Must be able to pass an eye exam – includes testing for: near vision, distance vision, color vision, depth perception, and ability to adjust focus.
• Must meet Occupational Demands/Physical Requirement checklist.
• Must be able to work at a biological safety cabinet for up to 2-3 hour test periods.
• Hepatitis B vaccine recommended.